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clinicaltrial [2021/04/05 11:47]
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clinicaltrial [2021/04/16 13:18] (当前版本)
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| TTFields临床试验列表，2021-4-5更新 | TTFields临床试验列表，2021-4-5更新 |
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| <text> | ---- |
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| Study List: | Study List: |
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| Study 1: | Study 1: |
| NCT Number: NCT04671459 | |
| Title: TTFields and Radiosurgery of Recurrent Glioblastoma +/- 18F-Fluoro-Ethyl-Thyrosine | NCT Number: NCT04671459 |
| Acronym: TaRRGET | |
| Status: Recruiting | Title: TTFields and Radiosurgery of Recurrent Glioblastoma +/- 18F-Fluoro-Ethyl-Thyrosine |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme|Recurrent Glioblastoma | Acronym: TaRRGET |
| Interventions: Combination Product: TTFields and SRS | |
| Outcome Measures: 1-year survival rate|Radiation necrosis range|Progression free survival (PFS)|Steroid needs until treatment failure|Patterns of failure|Objective response rates | Status: Recruiting |
| Sponsor/Collaborators: Prof. Franciszek Lukaszczyk Memorial Oncology Center|NovoCure GmbH | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma Multiforme|Recurrent Glioblastoma |
| Enrollment: 40 | |
| Funded Bys: Other|Industry | Interventions: Combination Product: TTFields and SRS |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: 1-year survival rate|Radiation necrosis range|Progression free survival (PFS)|Steroid needs until treatment failure|Patterns of failure|Objective response rates |
| Other IDs: KB 2020 | |
| Start Date: December 26, 2020 | Sponsor/Collaborators: Prof. Franciszek Lukaszczyk Memorial Oncology Center|NovoCure GmbH |
| Primary Completion Date: December 9, 2022 | |
| Completion Date: December 9, 2023 | Gender: All |
| First Posted: December 17, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: January 26, 2021 | |
| Locations: The Franciszek Lukaszczyk Oncology Center, Bydgoszcz, Poland | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04671459 | Enrollment: 40 |
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| | Funded Bys: Other|Industry |
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| | Study Type: Interventional |
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| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
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| | Other IDs: KB 2020 |
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| | Start Date: December 26, 2020 |
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| | Primary Completion Date: December 9, 2022 |
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| | Completion Date: December 9, 2023 |
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| | First Posted: December 17, 2020 |
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| | Results First Posted: |
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| | Last Update Posted: January 26, 2021 |
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| | Locations: The Franciszek Lukaszczyk Oncology Center, Bydgoszcz, Poland |
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| | Study Documents: |
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| | </WRAP> |
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| | URL: https://ClinicalTrials.gov/show/NCT04671459 |
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| | <WRAP center box 98%> |
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| Study 2: | Study 2: |
| NCT Number: NCT03258021 | |
| Title: TTFields In GErmany in Routine Clinical Care | NCT Number: NCT03258021 |
| Acronym: TIGER | |
| Status: Active, not recruiting | Title: TTFields In GErmany in Routine Clinical Care |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: TIGER |
| Interventions: Device: TTFields | |
| Outcome Measures: Time to death of any cause (overall survival (OS)) from diagnosis|Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time|Number of SAEs after start of TTFields treatment|Time of usage (compliance) of TTFields treatment over time|Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline|Changes in quality of life at month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline|Patients' reason(s) for refusing TTFields at baseline | Status: Active, not recruiting |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: | Conditions: Glioblastoma |
| Enrollment: 710 | |
| Funded Bys: Industry | Interventions: Device: TTFields |
| Study Type: Observational | |
| Study Designs: Observational Model: Other|Time Perspective: Prospective | Outcome Measures: Time to death of any cause (overall survival (OS)) from diagnosis|Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time|Number of SAEs after start of TTFields treatment|Time of usage (compliance) of TTFields treatment over time|Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline|Changes in quality of life at month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline|Patients' reason(s) for refusing TTFields at baseline |
| Other IDs: 05.07.2017 | |
| Start Date: August 31, 2017 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: June 2021 | |
| Completion Date: July 2021 | Gender: All |
| First Posted: August 22, 2017 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: January 28, 2021 | |
| Locations: Clinical center Aschaffenburg-Alzenau, Aschaffenburg, Bavaria, Germany | Phases: |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03258021 | Enrollment: 710 |
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| | Funded Bys: Industry |
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| | Study Type: Observational |
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| | Study Designs: Observational Model: Other|Time Perspective: Prospective |
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| | Other IDs: 05.07.2017 |
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| | Start Date: August 31, 2017 |
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| | Primary Completion Date: June 2021 |
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| | Completion Date: July 2021 |
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| | First Posted: August 22, 2017 |
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| | Results First Posted: |
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| | Last Update Posted: January 28, 2021 |
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| | Locations: Clinical center Aschaffenburg-Alzenau, Aschaffenburg, Bavaria, Germany |
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| | Study Documents: |
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| | </WRAP> |
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| | URL: https://ClinicalTrials.gov/show/NCT03258021 |
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| | <WRAP center box 98%> |
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| Study 3: | Study 3: |
| NCT Number: NCT04717739 | |
| Title: TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study | NCT Number: NCT04717739 |
| Acronym: | |
| Status: Not yet recruiting | Title: TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Device: TTFields | |
| Outcome Measures: Time of usage of TTFields treatment in follow-up derived from monitoring data of the devices, standardised to usage days, as measure of compliance with TTFields treatment.|Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU time|Changes in daily physical activity as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy|Changes in sleep quality as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy|Changes in neurocognitive functioning as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy. | Status: Not yet recruiting |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: | Conditions: Glioblastoma |
| Enrollment: 500 | |
| Funded Bys: Industry | Interventions: Device: TTFields |
| Study Type: Observational | |
| Study Designs: Observational Model: Other|Time Perspective: Prospective | Outcome Measures: Time of usage of TTFields treatment in follow-up derived from monitoring data of the devices, standardised to usage days, as measure of compliance with TTFields treatment.|Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU time|Changes in daily physical activity as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy|Changes in sleep quality as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy|Changes in neurocognitive functioning as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy. |
| Other IDs: 13.01.2021 | |
| Start Date: March 2021 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: June 1, 2023 | |
| Completion Date: July 1, 2023 | Gender: All |
| First Posted: January 22, 2021 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: January 22, 2021 | |
| Locations: University Hospital Essen, Essen, Germany | Phases: |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04717739 | Enrollment: 500 |
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| | Funded Bys: Industry |
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| | Study Type: Observational |
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| | Study Designs: Observational Model: Other|Time Perspective: Prospective |
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| | Other IDs: 13.01.2021 |
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| | Start Date: March 2021 |
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| | Primary Completion Date: June 1, 2023 |
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| | Completion Date: July 1, 2023 |
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| | First Posted: January 22, 2021 |
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| | Results First Posted: |
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| | Last Update Posted: January 22, 2021 |
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| | Locations: University Hospital Essen, Essen, Germany |
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| | Study Documents: |
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| | </WRAP> |
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| | URL: https://ClinicalTrials.gov/show/NCT04717739 |
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| | <WRAP center box 98%> |
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| Study 4: | Study 4: |
| NCT Number: NCT02973789 | |
| Title: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR) | NCT Number: NCT02973789 |
| Acronym: | |
| Status: Recruiting | Title: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR) |
| Study Results: No Results Available | |
| Conditions: Nonsmall Cell Lung Cancer | Acronym: |
| Interventions: Device: NovoTTF-100L|Drug: Immune checkpoint inhibitors or docetaxel | |
| Outcome Measures: Overall survival of patients treated with TTFields + docetaxel or immune checkpoint inhibitors vs. docetaxel or immune checkpoint inhibitors alone (superiority analysis)|Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis)|Overall survival of patients treated with TTFields + immune checkpoint inhibitors vs. immune checkpoint inhibitors alone (superiority)|Overall Survival of patients treated with TTFields + docetaxel Vs. immune checkpoint inhibitors alone (non-inferiority analysis)|Progression-free survival of patients treated with docetaxel or immune checkpoint inhibitors + TTFields vs. docetaxel or immune checkpoint inhibitors alone, based on RECIST Criteria|Overall radiological response rate (based on RECIST criteria) of patients treated with docetaxel or Immune checkpoint inhibitors + TTFields vs. docetaxel or immune checkpoint inhibitors alone.|Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum|Analyses of the effects of NovoTTF-100L with each type of immune checkpoint inhibitor on overall survival and progression free survival|Analysis of the effects of NovoTTF-100L on overall survival and progression free survival within each histological subgroup (squamous and non-squamous)|The effect of treatment compliance with NovoTTF-100L on overall survival and progression free survival outcomes|Adverse events, severity and frequency based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03 | Status: Recruiting |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 3 | Conditions: Nonsmall Cell Lung Cancer |
| Enrollment: 534 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L|Drug: Immune checkpoint inhibitors or docetaxel |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall survival of patients treated with TTFields + docetaxel or immune checkpoint inhibitors vs. docetaxel or immune checkpoint inhibitors alone (superiority analysis)|Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis)|Overall survival of patients treated with TTFields + immune checkpoint inhibitors vs. immune checkpoint inhibitors alone (superiority)|Overall Survival of patients treated with TTFields + docetaxel Vs. immune checkpoint inhibitors alone (non-inferiority analysis)|Progression-free survival of patients treated with docetaxel or immune checkpoint inhibitors + TTFields vs. docetaxel or immune checkpoint inhibitors alone, based on RECIST Criteria|Overall radiological response rate (based on RECIST criteria) of patients treated with docetaxel or Immune checkpoint inhibitors + TTFields vs. docetaxel or immune checkpoint inhibitors alone.|Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum|Analyses of the effects of NovoTTF-100L with each type of immune checkpoint inhibitor on overall survival and progression free survival|Analysis of the effects of NovoTTF-100L on overall survival and progression free survival within each histological subgroup (squamous and non-squamous)|The effect of treatment compliance with NovoTTF-100L on overall survival and progression free survival outcomes|Adverse events, severity and frequency based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03 |
| Other IDs: EF-24 | |
| Start Date: December 2016 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: September 2023 | |
| Completion Date: September 2023 | Gender: All |
| First Posted: November 25, 2016 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: March 24, 2021 | |
| Locations: Central Alabama Research, Birmingham, Alabama, United States|Ironwood Cancer & Research Center, Chandler, Arizona, United States|Cancer Center at St. Joseph Hospital and Medical Center, Phoenix, Arizona, United States|Beverly Hills Cancer Center, Beverly Hills, California, United States|California Cancer Associates for Research and Excellence, Inc. cCARE, Fresno, California, United States|Saddleback Memorial Medical Center, Laguna Hills, California, United States|Dignity Health - Mercy Cancer Centers, Sacramento, California, United States|Sutter Institute for Medical Research, Sacramento, California, United States|Innovative Clinical Research Institute, Whittier, California, United States|Banner MD Anderson Cancer Center at North Colorado Medical Center, Greeley, Colorado, United States|Associated Neurologists of Southern CT, P.C., Fairfield, Connecticut, United States|Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States|Mount Sinai Medical Center, Miami Beach, Florida, United States|Miami Cancer Institute, Miami, Florida, United States|AdventHealth Orlando, Orlando, Florida, United States|Adult Oncology Research, Orlando, Florida, United States|BRCR Medical Center INC, Plantation, Florida, United States|University of Illinois Cancer Center, Chicago, Illinois, United States|Illinois CancerCare, P.C., Peoria, Illinois, United States|Franciscan Health Indianapolis, Indianapolis, Indiana, United States|University of Kansas Cancer Center, Westwood, Kansas, United States|Norton Cancer Institute, Louisville, Kentucky, United States|University Medical Center, Inc; DBA University of Louisville, Louisville, Kentucky, United States|Tulane Cancer Center, New Orleans, Louisiana, United States|CHRISTUS Health, Shreveport, Louisiana, United States|Central Maine Medical Center, Lewiston, Maine, United States|University of Maryland School of Medicine, Baltimore, Maryland, United States|Tufts Medical Center, Division of Hematology and Oncology, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|Clinical Oncology Associates, Farmington Hills, Michigan, United States|Detroit Clinical Research Center, Farmington Hills, Michigan, United States|Saint Joseph Mercy Health System, Ypsilanti, Michigan, United States|Saint Luke's Cancer Institute, Kansas City, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|CHI Health Research Center, Omaha, Nebraska, United States|Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|Renown Regional Medical Center Institute for Cancer, Reno, Nevada, United States|Presbyterian Cancer Center, Albuquerque, New Mexico, United States|New York-Presbyterian/Queens Radiation Oncology, Flushing, New York, United States|Northern Westchester Hospital, Mount Kisco, New York, United States|Stony Brook Cancer Center, Stony Brook, New York, United States|Oncology Specialists of Charlotte, Charlotte, North Carolina, United States|W.G. Bill Hefner VA Med Center, Salisbury, North Carolina, United States|Piedmont Radiation Oncology, PA, Winston-Salem, North Carolina, United States|Summa Health, Akron, Ohio, United States|Toledo Clinic Cancer Center, Toledo, Ohio, United States|Vita Medical Associates, P.C., Bethlehem, Pennsylvania, United States|Geisinger Cancer Institute, Danville, Pennsylvania, United States|UT/Erlanger Oncology & Hematology, Chattanooga, Tennessee, United States|Texas Oncology - Amarillo, Amarillo, Texas, United States|Texas Oncology - Arlington, Arlington, Texas, United States|Christus Health Spohn Ministry, Corpus Christi, Texas, United States|Dallas VA Medical Center, Dallas, Texas, United States|Texas Oncology- Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States|The University of Texas Southwestern Medical Center, Dallas, Texas, United States|Oncology Consultants, P.A., Houston, Texas, United States|Texas Oncology-McKinney, McKinney, Texas, United States|Texas Oncology - Paris, Paris, Texas, United States|Texas Oncology- Plano West, Plano, Texas, United States|Baylor Scott & White Health/McClinton Cancer Center, Waco, Texas, United States|Texas Oncology-Waco, Waco, Texas, United States|Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States|Overlake Medical Center & Clinics, Bellevue, Washington, United States|UW Carbone Cancer Center, Madison, Wisconsin, United States|Uniklinikum Salzburg Landeskrankenhaus - Universitätsklinik für Innere Medizin III der PMU, Salzburg, Austria|Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology, Brussels, Belgium|André Renard Clinic, Herstal, Belgium|AZ Sint Maarten, Mechelen, Belgium|McGill University Health Centre, Montréal, Quebec, Canada|Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS), Sherbrooke, Quebec, Canada|Allan Blair Cancer Center, Regina, Saskatchewan, Canada|Thomayerova Nemocnice Dept. of Pneumology, Prague, Czechia|Všeobecná Fakultní Nemocnice, Prague, Czechia|Vitkovicka nemocnice, Vitkovice, Czechia|Centre Hospitalier de Beauvais, Beauvais, France|INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer, Bordeaux, France|Hospital Centre of Brittany SUDF (CHBS), Lorient, France|CHU de Nîmes ICG. - Service de pneumologie, Nîmes, France|Hôpital Saint-Louis, Paris, France|Hospital Centre of Saint-Quentin, Saint-Quentin, France|Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV Onkologie/Hämatologie, Halle (Saale), Germany|Azienda Sociosanitaria Ligure 3 (ASL 3), Genova, Italy|IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy|UOC Oncologia Medica Presidio Ospedaliero di Ravenna, Ravenna, Italy|ASST della Valle Olona - Presidio Ospedaliero di Saronno, Saronno, Italy|St Jansdal Ziekenhuis, Harderwijk, Netherlands|Erasmus Mc, Rotterdam, Netherlands|Uniwersyteckie Centrum Kliniczne, Gdansk, Poland|MS Clinsearch Specjalistyczny NZOZ, Lublin, Poland|Katedra i Klinika Onkologii; Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu, Poznan, Poland|Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie, Oddział Onkologii Klinicznej i Chemioterapii, Szczecin, Poland|Centrum Terapii Współczesnej, Łódź, Poland|Hospital Universitario Arnau de Vilanova, Lleida, Catalonia, Spain|Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell, Barcelona, Spain|HGU Gregorio Marañón, Madrid, Spain|Hospital Universitario 12 de Octubre, Madrid, Spain|Hospital Universitario Puerta de Hierro, Madrid, Spain|Hospital Universitario Málaga Regional. IBIMA, Málaga, Spain|Hospital Virgen de la Salud, Toledo, Spain|Hospital Universitari i Politécnic La Fe, Valencia, Spain|KS Winterthur, Medizinische Onkologie, Winterthur, Switzerland | Phases: Phase 3 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02973789 | Enrollment: 534 |
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| | Funded Bys: Industry |
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| | Study Type: Interventional |
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| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
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| | Other IDs: EF-24 |
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| | Start Date: December 2016 |
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| | Primary Completion Date: September 2023 |
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| | Completion Date: September 2023 |
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| | First Posted: November 25, 2016 |
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| | Results First Posted: |
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| | Last Update Posted: March 24, 2021 |
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| | Locations: Central Alabama Research, Birmingham, Alabama, United States|Ironwood Cancer & Research Center, Chandler, Arizona, United States|Cancer Center at St. Joseph Hospital and Medical Center, Phoenix, Arizona, United States|Beverly Hills Cancer Center, Beverly Hills, California, United States|California Cancer Associates for Research and Excellence, Inc. cCARE, Fresno, California, United States|Saddleback Memorial Medical Center, Laguna Hills, California, United States|Dignity Health - Mercy Cancer Centers, Sacramento, California, United States|Sutter Institute for Medical Research, Sacramento, California, United States|Innovative Clinical Research Institute, Whittier, California, United States|Banner MD Anderson Cancer Center at North Colorado Medical Center, Greeley, Colorado, United States|Associated Neurologists of Southern CT, P.C., Fairfield, Connecticut, United States|Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States|Mount Sinai Medical Center, Miami Beach, Florida, United States|Miami Cancer Institute, Miami, Florida, United States|AdventHealth Orlando, Orlando, Florida, United States|Adult Oncology Research, Orlando, Florida, United States|BRCR Medical Center INC, Plantation, Florida, United States|University of Illinois Cancer Center, Chicago, Illinois, United States|Illinois CancerCare, P.C., Peoria, Illinois, United States|Franciscan Health Indianapolis, Indianapolis, Indiana, United States|University of Kansas Cancer Center, Westwood, Kansas, United States|Norton Cancer Institute, Louisville, Kentucky, United States|University Medical Center, Inc; DBA University of Louisville, Louisville, Kentucky, United States|Tulane Cancer Center, New Orleans, Louisiana, United States|CHRISTUS Health, Shreveport, Louisiana, United States|Central Maine Medical Center, Lewiston, Maine, United States|University of Maryland School of Medicine, Baltimore, Maryland, United States|Tufts Medical Center, Division of Hematology and Oncology, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|Clinical Oncology Associates, Farmington Hills, Michigan, United States|Detroit Clinical Research Center, Farmington Hills, Michigan, United States|Saint Joseph Mercy Health System, Ypsilanti, Michigan, United States|Saint Luke's Cancer Institute, Kansas City, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|CHI Health Research Center, Omaha, Nebraska, United States|Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|Renown Regional Medical Center Institute for Cancer, Reno, Nevada, United States|Presbyterian Cancer Center, Albuquerque, New Mexico, United States|New York-Presbyterian/Queens Radiation Oncology, Flushing, New York, United States|Northern Westchester Hospital, Mount Kisco, New York, United States|Stony Brook Cancer Center, Stony Brook, New York, United States|Oncology Specialists of Charlotte, Charlotte, North Carolina, United States|W.G. Bill Hefner VA Med Center, Salisbury, North Carolina, United States|Piedmont Radiation Oncology, PA, Winston-Salem, North Carolina, United States|Summa Health, Akron, Ohio, United States|Toledo Clinic Cancer Center, Toledo, Ohio, United States|Vita Medical Associates, P.C., Bethlehem, Pennsylvania, United States|Geisinger Cancer Institute, Danville, Pennsylvania, United States|UT/Erlanger Oncology & Hematology, Chattanooga, Tennessee, United States|Texas Oncology - Amarillo, Amarillo, Texas, United States|Texas Oncology - Arlington, Arlington, Texas, United States|Christus Health Spohn Ministry, Corpus Christi, Texas, United States|Dallas VA Medical Center, Dallas, Texas, United States|Texas Oncology- Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States|The University of Texas Southwestern Medical Center, Dallas, Texas, United States|Oncology Consultants, P.A., Houston, Texas, United States|Texas Oncology-McKinney, McKinney, Texas, United States|Texas Oncology - Paris, Paris, Texas, United States|Texas Oncology- Plano West, Plano, Texas, United States|Baylor Scott & White Health/McClinton Cancer Center, Waco, Texas, United States|Texas Oncology-Waco, Waco, Texas, United States|Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States|Overlake Medical Center & Clinics, Bellevue, Washington, United States|UW Carbone Cancer Center, Madison, Wisconsin, United States|Uniklinikum Salzburg Landeskrankenhaus - Universitätsklinik für Innere Medizin III der PMU, Salzburg, Austria|Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology, Brussels, Belgium|André Renard Clinic, Herstal, Belgium|AZ Sint Maarten, Mechelen, Belgium|McGill University Health Centre, Montréal, Quebec, Canada|Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS), Sherbrooke, Quebec, Canada|Allan Blair Cancer Center, Regina, Saskatchewan, Canada|Thomayerova Nemocnice Dept. of Pneumology, Prague, Czechia|Všeobecná Fakultní Nemocnice, Prague, Czechia|Vitkovicka nemocnice, Vitkovice, Czechia|Centre Hospitalier de Beauvais, Beauvais, France|INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer, Bordeaux, France|Hospital Centre of Brittany SUDF (CHBS), Lorient, France|CHU de Nîmes ICG. - Service de pneumologie, Nîmes, France|Hôpital Saint-Louis, Paris, France|Hospital Centre of Saint-Quentin, Saint-Quentin, France|Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV Onkologie/Hämatologie, Halle (Saale), Germany|Azienda Sociosanitaria Ligure 3 (ASL 3), Genova, Italy|IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, Italy|UOC Oncologia Medica Presidio Ospedaliero di Ravenna, Ravenna, Italy|ASST della Valle Olona - Presidio Ospedaliero di Saronno, Saronno, Italy|St Jansdal Ziekenhuis, Harderwijk, Netherlands|Erasmus Mc, Rotterdam, Netherlands|Uniwersyteckie Centrum Kliniczne, Gdansk, Poland|MS Clinsearch Specjalistyczny NZOZ, Lublin, Poland|Katedra i Klinika Onkologii; Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu, Poznan, Poland|Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie, Oddział Onkologii Klinicznej i Chemioterapii, Szczecin, Poland|Centrum Terapii Współczesnej, Łódź, Poland|Hospital Universitario Arnau de Vilanova, Lleida, Catalonia, Spain|Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell, Barcelona, Spain|HGU Gregorio Marañón, Madrid, Spain|Hospital Universitario 12 de Octubre, Madrid, Spain|Hospital Universitario Puerta de Hierro, Madrid, Spain|Hospital Universitario Málaga Regional. IBIMA, Málaga, Spain|Hospital Virgen de la Salud, Toledo, Spain|Hospital Universitari i Politécnic La Fe, Valencia, Spain|KS Winterthur, Medizinische Onkologie, Winterthur, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02973789 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 5: | Study 5: |
| NCT Number: NCT04492163 | |
| Title: Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM | NCT Number: NCT04492163 |
| Acronym: | |
| Status: Recruiting | Title: Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme | Acronym: |
| Interventions: Device: TTFields | |
| Outcome Measures: Progression free survival (PFS)|Overall Survival (OS)|Progression Free Survival at 6 months (PFS6)|1-year and 2-year survival rates|Overall radiological response|Severity and frequency of adverse events|Pathological changes in resected GBM tumors following study treatment|Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed|Dependence of Overall Survival on TTFields dose delivered to the tumor bed | Status: Recruiting |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma Multiforme |
| Enrollment: 25 | |
| Funded Bys: Industry | Interventions: Device: TTFields |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Progression free survival (PFS)|Overall Survival (OS)|Progression Free Survival at 6 months (PFS6)|1-year and 2-year survival rates|Overall radiological response|Severity and frequency of adverse events|Pathological changes in resected GBM tumors following study treatment|Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed|Dependence of Overall Survival on TTFields dose delivered to the tumor bed |
| Other IDs: EF-33 | |
| Start Date: July 14, 2020 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: January 2022 | |
| Completion Date: January 2022 | Gender: All |
| First Posted: July 30, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: November 24, 2020 | |
| Locations: Nemocnice Na Homolce, Prague, Czechia | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04492163 | Enrollment: 25 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-33 |
| | |
| | Start Date: July 14, 2020 |
| | |
| | Primary Completion Date: January 2022 |
| | |
| | Completion Date: January 2022 |
| | |
| | First Posted: July 30, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: November 24, 2020 |
| | |
| | Locations: Nemocnice Na Homolce, Prague, Czechia |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04492163 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 6: | Study 6: |
| NCT Number: NCT03606590 | |
| Title: Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA) | NCT Number: NCT03606590 |
| Acronym: | |
| Status: Active, not recruiting | Title: Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA) |
| Study Results: No Results Available | |
| Conditions: Hepatocellular Carcinoma | Acronym: |
| Interventions: Device: NovoTTF-100L(P) device|Drug: Sorafenib | |
| Outcome Measures: Overall response rate|In-field control rate at one year|Overall survival|Progression Free Survival|Distant metastases-free survival rate at 1 year|Overall survival at one year|Progression free survival at 6 and 12 months|Severity and frequency of adverse events | Status: Active, not recruiting |
| Sponsor/Collaborators: NovoCure GmbH|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Hepatocellular Carcinoma |
| Enrollment: 25 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L(P) device|Drug: Sorafenib |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall response rate|In-field control rate at one year|Overall survival|Progression Free Survival|Distant metastases-free survival rate at 1 year|Overall survival at one year|Progression free survival at 6 and 12 months|Severity and frequency of adverse events |
| Other IDs: EF-30 | |
| Start Date: February 15, 2019 | Sponsor/Collaborators: NovoCure GmbH|NovoCure Ltd. |
| Primary Completion Date: September 2021 | |
| Completion Date: September 2021 | Gender: All |
| First Posted: July 31, 2018 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: July 29, 2020 | |
| Locations: University Hospital Fakultni Nemocnice Olomouc, Oncology Clinic, Olomouc, Czechia|CHU de Nantes, Nantes Cedex 01, France|University Medical Center - University of Freiburg, Freiburg, Germany|Ulm University Hospital, Ulm, Germany|Università Campus Bio-Medico di Roma, Rome, Italy|Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu, Poznań, Poland|Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain|HM Hospitales - Centro Integral Oncológico Clara Campal, Madrid, Spain | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03606590 | Enrollment: 25 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-30 |
| | |
| | Start Date: February 15, 2019 |
| | |
| | Primary Completion Date: September 2021 |
| | |
| | Completion Date: September 2021 |
| | |
| | First Posted: July 31, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: July 29, 2020 |
| | |
| | Locations: University Hospital Fakultni Nemocnice Olomouc, Oncology Clinic, Olomouc, Czechia|CHU de Nantes, Nantes Cedex 01, France|University Medical Center - University of Freiburg, Freiburg, Germany|Ulm University Hospital, Ulm, Germany|Università Campus Bio-Medico di Roma, Rome, Italy|Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu, Poznań, Poland|Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain|HM Hospitales - Centro Integral Oncológico Clara Campal, Madrid, Spain |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03606590 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 7: | Study 7: |
| NCT Number: NCT03377491 | |
| Title: Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3) | NCT Number: NCT03377491 |
| Acronym: | |
| Status: Recruiting | Title: Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3) |
| Study Results: No Results Available | |
| Conditions: Pancreas Adenocarcinoma | Acronym: |
| Interventions: Device: NovoTTF-100L(P)|Drug: Gemcitabine|Drug: nab paclitaxel | |
| Outcome Measures: Overall survival|Progression-free survival|Local progression-free survival|Objective response rate|One-year survival rate|Quality of life|Pain-free survival|Puncture-free survival|Resectability rate|Toxicity profile | Status: Recruiting |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 3 | Conditions: Pancreas Adenocarcinoma |
| Enrollment: 556 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L(P)|Drug: Gemcitabine|Drug: nab paclitaxel |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall survival|Progression-free survival|Local progression-free survival|Objective response rate|One-year survival rate|Quality of life|Pain-free survival|Puncture-free survival|Resectability rate|Toxicity profile |
| Other IDs: EF-27 | |
| Start Date: May 10, 2018 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: September 2023 | |
| Completion Date: September 2023 | Gender: All |
| First Posted: December 19, 2017 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: March 11, 2021 | |
| Locations: Grandview Medical Center, Cancer Center, Birmingham, Alabama, United States|Infirmary Cancer Care, Mobile, Alabama, United States|Banner MD Anderson Cancer Center, Gilbert, Arizona, United States|Arizona Oncology Associates, PC- HOPE - US Oncology Research, Tucson, Arizona, United States|University of Arizona Cancer Center, Tucson, Arizona, United States|Pacific Cancer Medical Center, Anaheim, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|Dignity Health - Mercy Cancer Centers, Sacramento, California, United States|Sutter Cancer Center Sacramento, Sacramento, California, United States|Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton, Florida, United States|Mount Sinai Medical Center, Miami Beach, Florida, United States|AdventHealth Neuro Oncology, Orlando, Florida, United States|BRCR Medical Center INC, Plantation, Florida, United States|Florida Cancer Specialists, Saint Petersburg, Florida, United States|Florida Hospital Tampa, Tampa, Florida, United States|Piedmont Cancer Institute, Atlanta, Georgia, United States|Illinois Cancer Specialist - US Oncology Research, Arlington Heights, Illinois, United States|Rush University Medical Center, Chicago, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|University of Kansas Medical Cancer Center, Fairway, Kansas, United States|Norton Cancer Institute, Norton Healthcare Pavilion, Louisville, Kentucky, United States|Ochsner Medical Center, New Orleans, Louisiana, United States|Central Maine Medical Center, Clinical Research Department, Lewiston, Maine, United States|University of Maryland Comprehensive Cancer Center, Baltimore, Maryland, United States|Maryland Oncology Hematology, P.A - US Oncology Research, Columbia, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|UMass Memorial Medical Center, Worcester, Massachusetts, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|Cancer and Hematology Centers of Western Michigan, PC, Grand Rapids, Michigan, United States|University of Minnesota, Minneapolis, Minnesota, United States|MidAmerica Division, Kansas City, Missouri, United States|Nebraska Methodist Hospital, Omaha, Nebraska, United States|Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States|Kaleida Health, Buffalo, New York, United States|NYU Langone Arena Oncology, Lake Success, New York, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States|Willamette Valley Cancer Institute and Research Center - US Oncology Research, Eugene, Oregon, United States|Geisinger Medical Center, Danville, Pennsylvania, United States|Vita Medical Associates, P.C., Fountain Hill, Pennsylvania, United States|UT/Erlanger Oncology & Hematology, Chattanooga, Tennessee, United States|Tennessee Oncology, Nashville, Tennessee, United States|Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research, Beaumont, Texas, United States|Texas Oncology - Bedford - US Oncology Reasearch, Bedford, Texas, United States|Methodist Regional Cancer Center, Dallas, Texas, United States|Texas Oncology - Baylor - US Oncology Research, Dallas, Texas, United States|Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research, El Paso, Texas, United States|Houston Methodist Cancer Center, Houston, Texas, United States|Baylor Scott and White Medical Center, Temple, Texas, United States|Texas Oncology - Tyler - US Oncology Research, Tyler, Texas, United States|Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research, Roanoke, Virginia, United States|Vista Oncology Inc PS, Olympia, Washington, United States|Virginia Mason Medical Center, Seattle, Washington, United States|Seattle Cancer Care Alliance, Seattle, Washington, United States|West Virginia University Cancer Institute, Morgantown, West Virginia, United States|Medical University Graz, Graz, Austria|Univ. Klinik für Innere Medizin III der PMU, Salzburg, Austria|Landes-Krankenhaus Steyr, Steyr, Austria|London Regional Cancer Program, London Health Sciences Centre, London, Ontario, Canada|Centre Hospitalier de I'Universitaire de de Montreal (CHUM), Montréal, Quebec, Canada|Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada|University Hospital Centre Zagreb, Zagreb, Croatia|Nemocnice Nový Jičín, Nový Jičín, Czechia|University Hospital Olomouc, Olomouc, Czechia|General University Hospital in Prague, Praha 2, Czechia|Nemocnice Na Bulovce, Praha 8, Czechia|Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive, Pessac, Bordeaux, France|Institut de Cancérologie de l'Ouest, Angers cedex, France|Centre Hospitalier de Bretagne Sud /Site du Scorff, Lorient, France|Centre Léon Bérard, Lyon, France|Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine, Paris, France|Hôpital Privé des Côtes d'Armor, Plérin, France|Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale, Strasbourg, France|Queen Mary Hospital, Hong Kong, Hong Kong|National Institute of Oncology, Budapest, Hungary|Bekes County Hospital, Gyula, Hungary|Bacs-Kiskun County Hospital, Kecskemét, Hungary|Tolna County Hospital, Szekszárd, Hungary|Jasz-Nagykun-Szolnok County Hospital, Szolnok, Hungary|Rambam Health Care Campus, Oncology Institute, Haifa, Israel|Sourasky Medical Center, Oncology Department, Tel Aviv, Israel|A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy|Università Campus Bio-Medico di Rome, Roma, Italy|A.O.U Città della Salute e della Scienza di Torino, Torino, Italy|Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu, Poznań, Poland|Centrum Medyczne MrukMed, Rzeszów, Poland|Oncology and Radiotherapy Clinic, Oncology Center - Institute, Warsaw, Poland|Instituto Oncòlogico Dr. Rosell, Barcelona, Spain|Vall d´Hebron University Hospital, Barcelona, Spain|Hospital General Universitario de Elche, Elche, Spain|HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC, Madrid, Spain|Hospital Universitario Carlos Haya de Malaga, Málaga, Spain|Clinica Universiatria de Navarra, Pamplona, Spain|Hospital Universitario Marqués de Valdecilla, Santander, Spain|Instituto Valenciano de Oncología IVO, Valencia, Spain|Hôpital Fribourgeois/Freiburger Spital, Fribourg, Switzerland|KS Winterthur, Winterthur, Switzerland | Phases: Phase 3 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03377491 | Enrollment: 556 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-27 |
| | |
| | Start Date: May 10, 2018 |
| | |
| | Primary Completion Date: September 2023 |
| | |
| | Completion Date: September 2023 |
| | |
| | First Posted: December 19, 2017 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: March 11, 2021 |
| | |
| | Locations: Grandview Medical Center, Cancer Center, Birmingham, Alabama, United States|Infirmary Cancer Care, Mobile, Alabama, United States|Banner MD Anderson Cancer Center, Gilbert, Arizona, United States|Arizona Oncology Associates, PC- HOPE - US Oncology Research, Tucson, Arizona, United States|University of Arizona Cancer Center, Tucson, Arizona, United States|Pacific Cancer Medical Center, Anaheim, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|Dignity Health - Mercy Cancer Centers, Sacramento, California, United States|Sutter Cancer Center Sacramento, Sacramento, California, United States|Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton, Florida, United States|Mount Sinai Medical Center, Miami Beach, Florida, United States|AdventHealth Neuro Oncology, Orlando, Florida, United States|BRCR Medical Center INC, Plantation, Florida, United States|Florida Cancer Specialists, Saint Petersburg, Florida, United States|Florida Hospital Tampa, Tampa, Florida, United States|Piedmont Cancer Institute, Atlanta, Georgia, United States|Illinois Cancer Specialist - US Oncology Research, Arlington Heights, Illinois, United States|Rush University Medical Center, Chicago, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|University of Kansas Medical Cancer Center, Fairway, Kansas, United States|Norton Cancer Institute, Norton Healthcare Pavilion, Louisville, Kentucky, United States|Ochsner Medical Center, New Orleans, Louisiana, United States|Central Maine Medical Center, Clinical Research Department, Lewiston, Maine, United States|University of Maryland Comprehensive Cancer Center, Baltimore, Maryland, United States|Maryland Oncology Hematology, P.A - US Oncology Research, Columbia, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|UMass Memorial Medical Center, Worcester, Massachusetts, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|Cancer and Hematology Centers of Western Michigan, PC, Grand Rapids, Michigan, United States|University of Minnesota, Minneapolis, Minnesota, United States|MidAmerica Division, Kansas City, Missouri, United States|Nebraska Methodist Hospital, Omaha, Nebraska, United States|Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States|Kaleida Health, Buffalo, New York, United States|NYU Langone Arena Oncology, Lake Success, New York, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States|Willamette Valley Cancer Institute and Research Center - US Oncology Research, Eugene, Oregon, United States|Geisinger Medical Center, Danville, Pennsylvania, United States|Vita Medical Associates, P.C., Fountain Hill, Pennsylvania, United States|UT/Erlanger Oncology & Hematology, Chattanooga, Tennessee, United States|Tennessee Oncology, Nashville, Tennessee, United States|Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research, Beaumont, Texas, United States|Texas Oncology - Bedford - US Oncology Reasearch, Bedford, Texas, United States|Methodist Regional Cancer Center, Dallas, Texas, United States|Texas Oncology - Baylor - US Oncology Research, Dallas, Texas, United States|Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research, El Paso, Texas, United States|Houston Methodist Cancer Center, Houston, Texas, United States|Baylor Scott and White Medical Center, Temple, Texas, United States|Texas Oncology - Tyler - US Oncology Research, Tyler, Texas, United States|Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research, Roanoke, Virginia, United States|Vista Oncology Inc PS, Olympia, Washington, United States|Virginia Mason Medical Center, Seattle, Washington, United States|Seattle Cancer Care Alliance, Seattle, Washington, United States|West Virginia University Cancer Institute, Morgantown, West Virginia, United States|Medical University Graz, Graz, Austria|Univ. Klinik für Innere Medizin III der PMU, Salzburg, Austria|Landes-Krankenhaus Steyr, Steyr, Austria|London Regional Cancer Program, London Health Sciences Centre, London, Ontario, Canada|Centre Hospitalier de I'Universitaire de de Montreal (CHUM), Montréal, Quebec, Canada|Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada|University Hospital Centre Zagreb, Zagreb, Croatia|Nemocnice Nový Jičín, Nový Jičín, Czechia|University Hospital Olomouc, Olomouc, Czechia|General University Hospital in Prague, Praha 2, Czechia|Nemocnice Na Bulovce, Praha 8, Czechia|Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive, Pessac, Bordeaux, France|Institut de Cancérologie de l'Ouest, Angers cedex, France|Centre Hospitalier de Bretagne Sud /Site du Scorff, Lorient, France|Centre Léon Bérard, Lyon, France|Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine, Paris, France|Hôpital Privé des Côtes d'Armor, Plérin, France|Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale, Strasbourg, France|Queen Mary Hospital, Hong Kong, Hong Kong|National Institute of Oncology, Budapest, Hungary|Bekes County Hospital, Gyula, Hungary|Bacs-Kiskun County Hospital, Kecskemét, Hungary|Tolna County Hospital, Szekszárd, Hungary|Jasz-Nagykun-Szolnok County Hospital, Szolnok, Hungary|Rambam Health Care Campus, Oncology Institute, Haifa, Israel|Sourasky Medical Center, Oncology Department, Tel Aviv, Israel|A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy|Università Campus Bio-Medico di Rome, Roma, Italy|A.O.U Città della Salute e della Scienza di Torino, Torino, Italy|Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu, Poznań, Poland|Centrum Medyczne MrukMed, Rzeszów, Poland|Oncology and Radiotherapy Clinic, Oncology Center - Institute, Warsaw, Poland|Instituto Oncòlogico Dr. Rosell, Barcelona, Spain|Vall d´Hebron University Hospital, Barcelona, Spain|Hospital General Universitario de Elche, Elche, Spain|HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC, Madrid, Spain|Hospital Universitario Carlos Haya de Malaga, Málaga, Spain|Clinica Universiatria de Navarra, Pamplona, Spain|Hospital Universitario Marqués de Valdecilla, Santander, Spain|Instituto Valenciano de Oncología IVO, Valencia, Spain|Hôpital Fribourgeois/Freiburger Spital, Fribourg, Switzerland|KS Winterthur, Winterthur, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03377491 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 8: | Study 8: |
| NCT Number: NCT04689087 | |
| Title: A Prospective, Open-label, Single-arm Clinical Study | NCT Number: NCT04689087 |
| Acronym: | |
| Status: Recruiting | Title: A Prospective, Open-label, Single-arm Clinical Study |
| Study Results: No Results Available | |
| Conditions: Recurrent Glioblastoma Multiforme | Acronym: |
| Interventions: Combination Product: TTFields | |
| Outcome Measures: OS6|Overall survival at 12 months (OS12)|overall survival OS(refers to the time from enrollment to tumor disease death from various causes)|Progression-free survival PFS|security | Status: Recruiting |
| Sponsor/Collaborators: Sun Yat-sen University | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Recurrent Glioblastoma Multiforme |
| Enrollment: 40 | |
| Funded Bys: Other | Interventions: Combination Product: TTFields |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention | Outcome Measures: OS6|Overall survival at 12 months (OS12)|overall survival OS(refers to the time from enrollment to tumor disease death from various causes)|Progression-free survival PFS|security |
| Other IDs: M-TTFields | |
| Start Date: April 1, 2020 | Sponsor/Collaborators: Sun Yat-sen University |
| Primary Completion Date: July 1, 2021 | |
| Completion Date: July 1, 2022 | Gender: All |
| First Posted: December 30, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: December 30, 2020 | |
| Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04689087 | Enrollment: 40 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention |
| | |
| | Other IDs: M-TTFields |
| | |
| | Start Date: April 1, 2020 |
| | |
| | Primary Completion Date: July 1, 2021 |
| | |
| | Completion Date: July 1, 2022 |
| | |
| | First Posted: December 30, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: December 30, 2020 |
| | |
| | Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04689087 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 9: | Study 9: |
| NCT Number: NCT02397928 | |
| Title: Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) | NCT Number: NCT02397928 |
| Acronym: | |
| Status: Completed | Title: Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) |
| Study Results: No Results Available | |
| Conditions: Malignant Pleural Mesothelioma | Acronym: |
| Interventions: Device: NovoTTF-100L device|Drug: Pemetrexed|Drug: Cisplatin or Carboplatin | |
| Outcome Measures: Overall Survival|Progression Free Survival|Response Rate|Toxicity- incidence of adverse events | Status: Completed |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Malignant Pleural Mesothelioma |
| Enrollment: 82 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L device|Drug: Pemetrexed|Drug: Cisplatin or Carboplatin |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall Survival|Progression Free Survival|Response Rate|Toxicity- incidence of adverse events |
| Other IDs: EF-23 | |
| Start Date: February 2015 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: April 2018 | |
| Completion Date: April 2018 | Gender: All |
| First Posted: March 25, 2015 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 25, 2018 | |
| Locations: Antwerp University Hospital, Thoracic Oncology, Antwerp, Belgium|Goustave Roussy - Cancer Campus Grand Paris, Villejuif, France|Universitätsklinikum Halle (Saale), Halle, Germany|A.S.O. "SS Antonio e Biagio e Cesare Arrigo", Alessandria, Italy|Cliniche Humanitas Gavazzeni, Bergamo, Italy|Ospedale Villa Scassi, Genoa, Italy|Ospedaliera di Perugia, Perugia, Italy|Ospedaliero Universitaria Pisana, Pisa, Italy|Erasmus Mc, Rotterdam, Netherlands|Medical University Gdansk, Gdansk, Poland|Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu, Poznań, Poland|Klinika Nowotworów Pluca I Klatki Piersiowej, Warsaw, Poland|Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron, Barcelona, Spain | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02397928 | Enrollment: 82 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-23 |
| | |
| | Start Date: February 2015 |
| | |
| | Primary Completion Date: April 2018 |
| | |
| | Completion Date: April 2018 |
| | |
| | First Posted: March 25, 2015 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 25, 2018 |
| | |
| | Locations: Antwerp University Hospital, Thoracic Oncology, Antwerp, Belgium|Goustave Roussy - Cancer Campus Grand Paris, Villejuif, France|Universitätsklinikum Halle (Saale), Halle, Germany|A.S.O. "SS Antonio e Biagio e Cesare Arrigo", Alessandria, Italy|Cliniche Humanitas Gavazzeni, Bergamo, Italy|Ospedale Villa Scassi, Genoa, Italy|Ospedaliera di Perugia, Perugia, Italy|Ospedaliero Universitaria Pisana, Pisa, Italy|Erasmus Mc, Rotterdam, Netherlands|Medical University Gdansk, Gdansk, Poland|Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu, Poznań, Poland|Klinika Nowotworów Pluca I Klatki Piersiowej, Warsaw, Poland|Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron, Barcelona, Spain |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02397928 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 10: | Study 10: |
| NCT Number: NCT03940196 | |
| Title: Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3) | NCT Number: NCT03940196 |
| Acronym: | |
| Status: Recruiting | Title: Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3) |
| Study Results: No Results Available | |
| Conditions: Ovarian Cancer | Acronym: |
| Interventions: Device: NovoTTF-100L(O)|Drug: Paclitaxel | |
| Outcome Measures: Overall survival|Progression-free survival|Objective response rate|Next progression-free survival|Time to undisputable deterioration in health-related quality of life (HRQoL)|Time to first and second subsequent treatment|Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.|Severity and frequency of adverse events | Status: Recruiting |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: Female | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 3 | Conditions: Ovarian Cancer |
| Enrollment: 540 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L(O)|Drug: Paclitaxel |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall survival|Progression-free survival|Objective response rate|Next progression-free survival|Time to undisputable deterioration in health-related quality of life (HRQoL)|Time to first and second subsequent treatment|Quality of life using the EORTC QLQ C30 questionnaire with the ovarian cancer symptom OV28 module.|Severity and frequency of adverse events |
| Other IDs: EF-28 | |
| Start Date: March 22, 2019 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: September 2023 | |
| Completion Date: September 2023 | Gender: Female |
| First Posted: May 7, 2019 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: March 29, 2021 | |
| Locations: Arizona Oncology- Biltmore Cancer Center, Phoenix, Arizona, United States|Arizona Oncology, Tucson, Arizona, United States|California Pacific Medical Center- Pacific Campus, San Francisco, California, United States|Olive View - UCLA Medical Center, Sylmar, California, United States|Rocky Mountain Cancer Centers, Aurora, Colorado, United States|University of Colorado Denver, Aurora, Colorado, United States|Rocky Mountain Cancer Centers, Boulder, Colorado, United States|Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States|Rocky Mountain Cancer Centers, Denver, Colorado, United States|Rocky Mountain Cancer Centers, Denver, Colorado, United States|Rocky Mountain Cancer Centers, Lakewood, Colorado, United States|Rocky Mountain Cancer Centers, Littleton, Colorado, United States|Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States|Rocky Mountain Cancer Centers, Longmont, Colorado, United States|Rocky Mountain Cancer Centers, Parker, Colorado, United States|Rocky Mountain Cancer Centers, Pueblo, Colorado, United States|Rocky Mountain Cancer Centers, Thornton, Colorado, United States|AdventHealth Cancer Institute, Orlando, Florida, United States|Northeast Georgia Medical Center, Gainesville, Georgia, United States|Rush University Cancer Center - Chicago and Innovation, Chicago, Illinois, United States|Des Moines Oncology Research Association, Des Moines, Iowa, United States|Norton Cancer Institute, Louisville, Kentucky, United States|Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States|Lahey Hospital & Medical Center, Burlington, Massachusetts, United States|Minnesota Oncology Hematology, PA, Saint Paul, Minnesota, United States|Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States|Methodist Estabrook Cancer Center, Omaha, Nebraska, United States|Women's Cancer Center of Nevada, Las Vegas, Nevada, United States|Center of Hope at Renown Medical Center, Reno, Nevada, United States|MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States|Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States|Miami Valley Hospital South, Centerville, Ohio, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, United States|Northwest Cancer Specialists, PC, Portland, Oregon, United States|West Penn OB/GYN, Pittsburgh, Pennsylvania, United States|UPMC Cancer Center, Pittsburgh, Pennsylvania, United States|Abington Hospital- Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States|Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States|Sanford Gynecologic Oncology Clinic, Sioux Falls, South Dakota, United States|Texas Oncology Austin-Balcones, Austin, Texas, United States|Texas Oncology Austin-Midtown, Austin, Texas, United States|Texas Oncology Austin-North Austin, Austin, Texas, United States|University of Texas Southwestern Medical Center, Dallas, Texas, United States|Texas Oncology, Dallas, Texas, United States|Texas Oncology-Fort Worth, Fort Worth, Texas, United States|The University of Texas Medical School at Houston, Houston, Texas, United States|Texas Oncology-McAllen, McAllen, Texas, United States|Texas Oncology San Antonio Medical Center, San Antonio, Texas, United States|Texas Oncology - Sugar Land, Sugar Land, Texas, United States|Texas Oncology, The Woodlands, Texas, United States|Texas Oncology-Tyler, Tyler, Texas, United States|Texas Oncology-Deke Slayton Cancer Center, Webster, Texas, United States|Virginia Oncology Associates, Norfolk, Virginia, United States|Carilion Clinic-Gynecologic Oncology, Roanoke, Virginia, United States|Multicare Institute for Research and Innovation, Tacoma, Washington, United States|KH der Barmherzigen Brüder Graz, Graz, Austria|Univ.-Klinik für Gynäkologie und Geburtshilfe, Graz, Austria|Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck, Innsbruck, Austria|Landesfrauenklinik Salzburg, Salzburg, Austria|Imelda Ziekenhuis Bonheiden, Bonheiden, Belgium|Cliniques Universitaires Saint Luc, Institut Roi Albert II, Brussel, Belgium|Grand Hôpital de Charleroi, Oncologie-Hématologie, Charleroi, Belgium|AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent, Gent, Belgium|UZ Gent, Gent, Belgium|University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium|CHU Ambroise Paré, Mons, Belgium|CHU UCL Namur - Site Ste Elisabeth, Namur, Belgium|UCL-CUL Mont Godinne, Yvoir, Belgium|Onkologická Klinika Fakultní nemocnice Olomouc, Olomouc, Czechia|University Hospital Ostrava, Ostrava-Poruba, Czechia|Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady, Praha 10, Czechia|Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha 2, Czechia|Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s., České Budějovice, Czechia|Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie, Berlin, Germany|Universitätsklinikum Carl Gustav Carus, Dresden, Germany|Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department, Wiesbaden, Germany|Nőgyógyászati Osztály, Országos Onkológiai Intézet, Budapest, Hungary|Szuleszeti és Nogyogyaszati Klinika, Debrecen, Hungary|Hillel Yaffe Medical Center, Hadera, Israel|Saare Zedek Medical Center - Gyneco-Oncology, Jerusalem, Israel|Oncology Institute, Galilee Medical Center, Nahariya, Israel|Gyneco-Oncology Chaim Sheba Medical Center, Ramat Gan, Israel|Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy|Presidio Ospedaliero Antonio Perrino - ASL Brindisi, Brindisi, Italy|ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico, Lecco, Italy|Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia, Milano, Italy|IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO, Milano, Italy|Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy|Fondazione Policlinico Universitario Gemelli, Roma, Italy|University Saint Anna, Torino, Italy|Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała, Kraków, Poland|Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej, Olsztyn, Poland|Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu, Poznań, Poland|Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus, Barcelona, Spain|lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,, Girona, Spain|Clinica Universidad de Navarra en Madrid, Madrid, Spain|Hospital MD Anderson Cancer Center, Madrid, Spain|Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica, Madrid, Spain|Hospital 12 de Octubre. Servicio Oncología Médica, Madrid, Spain|Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases, Palma De Mallorca, Spain|Gynecological Tumor Center, University Hospital Basel, Basel, Switzerland|IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland|Kantonsspital Frauenfeld - Frauenklinik, Frauenfeld, Switzerland|UniversitätsSpital Zürich - Klinik für Gynäkologie, Zürich, Switzerland | Phases: Phase 3 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03940196 | Enrollment: 540 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-28 |
| | |
| | Start Date: March 22, 2019 |
| | |
| | Primary Completion Date: September 2023 |
| | |
| | Completion Date: September 2023 |
| | |
| | First Posted: May 7, 2019 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: March 29, 2021 |
| | |
| | Locations: Arizona Oncology- Biltmore Cancer Center, Phoenix, Arizona, United States|Arizona Oncology, Tucson, Arizona, United States|California Pacific Medical Center- Pacific Campus, San Francisco, California, United States|Olive View - UCLA Medical Center, Sylmar, California, United States|Rocky Mountain Cancer Centers, Aurora, Colorado, United States|University of Colorado Denver, Aurora, Colorado, United States|Rocky Mountain Cancer Centers, Boulder, Colorado, United States|Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States|Rocky Mountain Cancer Centers, Denver, Colorado, United States|Rocky Mountain Cancer Centers, Denver, Colorado, United States|Rocky Mountain Cancer Centers, Lakewood, Colorado, United States|Rocky Mountain Cancer Centers, Littleton, Colorado, United States|Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States|Rocky Mountain Cancer Centers, Longmont, Colorado, United States|Rocky Mountain Cancer Centers, Parker, Colorado, United States|Rocky Mountain Cancer Centers, Pueblo, Colorado, United States|Rocky Mountain Cancer Centers, Thornton, Colorado, United States|AdventHealth Cancer Institute, Orlando, Florida, United States|Northeast Georgia Medical Center, Gainesville, Georgia, United States|Rush University Cancer Center - Chicago and Innovation, Chicago, Illinois, United States|Des Moines Oncology Research Association, Des Moines, Iowa, United States|Norton Cancer Institute, Louisville, Kentucky, United States|Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States|Lahey Hospital & Medical Center, Burlington, Massachusetts, United States|Minnesota Oncology Hematology, PA, Saint Paul, Minnesota, United States|Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States|Methodist Estabrook Cancer Center, Omaha, Nebraska, United States|Women's Cancer Center of Nevada, Las Vegas, Nevada, United States|Center of Hope at Renown Medical Center, Reno, Nevada, United States|MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States|Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States|Miami Valley Hospital South, Centerville, Ohio, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, United States|Northwest Cancer Specialists, PC, Portland, Oregon, United States|West Penn OB/GYN, Pittsburgh, Pennsylvania, United States|UPMC Cancer Center, Pittsburgh, Pennsylvania, United States|Abington Hospital- Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States|Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States|Sanford Gynecologic Oncology Clinic, Sioux Falls, South Dakota, United States|Texas Oncology Austin-Balcones, Austin, Texas, United States|Texas Oncology Austin-Midtown, Austin, Texas, United States|Texas Oncology Austin-North Austin, Austin, Texas, United States|University of Texas Southwestern Medical Center, Dallas, Texas, United States|Texas Oncology, Dallas, Texas, United States|Texas Oncology-Fort Worth, Fort Worth, Texas, United States|The University of Texas Medical School at Houston, Houston, Texas, United States|Texas Oncology-McAllen, McAllen, Texas, United States|Texas Oncology San Antonio Medical Center, San Antonio, Texas, United States|Texas Oncology - Sugar Land, Sugar Land, Texas, United States|Texas Oncology, The Woodlands, Texas, United States|Texas Oncology-Tyler, Tyler, Texas, United States|Texas Oncology-Deke Slayton Cancer Center, Webster, Texas, United States|Virginia Oncology Associates, Norfolk, Virginia, United States|Carilion Clinic-Gynecologic Oncology, Roanoke, Virginia, United States|Multicare Institute for Research and Innovation, Tacoma, Washington, United States|KH der Barmherzigen Brüder Graz, Graz, Austria|Univ.-Klinik für Gynäkologie und Geburtshilfe, Graz, Austria|Univ.-Klinik für Gynäkologie und Geburtshilfe, Innsbruck, Innsbruck, Austria|Landesfrauenklinik Salzburg, Salzburg, Austria|Imelda Ziekenhuis Bonheiden, Bonheiden, Belgium|Cliniques Universitaires Saint Luc, Institut Roi Albert II, Brussel, Belgium|Grand Hôpital de Charleroi, Oncologie-Hématologie, Charleroi, Belgium|AZ Maria Middelares, Clinical Trial Unit Medical Oncology - Integrated Cancer Center Ghent, Gent, Belgium|UZ Gent, Gent, Belgium|University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium|CHU Ambroise Paré, Mons, Belgium|CHU UCL Namur - Site Ste Elisabeth, Namur, Belgium|UCL-CUL Mont Godinne, Yvoir, Belgium|Onkologická Klinika Fakultní nemocnice Olomouc, Olomouc, Czechia|University Hospital Ostrava, Ostrava-Poruba, Czechia|Gynekologicko-porodnická klinika, Fakultní nemocnice Královské Vinohrady, Praha 10, Czechia|Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha 2, Czechia|Gynekologicko-porodnické oddělení - Nemocnice České Budějovice a.s., České Budějovice, Czechia|Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Gynäkologie, Berlin, Germany|Universitätsklinikum Carl Gustav Carus, Dresden, Germany|Horst-Schmidt-Kliniken, Gynecology and Gynecologic, Oncology Department, Wiesbaden, Germany|Nőgyógyászati Osztály, Országos Onkológiai Intézet, Budapest, Hungary|Szuleszeti és Nogyogyaszati Klinika, Debrecen, Hungary|Hillel Yaffe Medical Center, Hadera, Israel|Saare Zedek Medical Center - Gyneco-Oncology, Jerusalem, Israel|Oncology Institute, Galilee Medical Center, Nahariya, Israel|Gyneco-Oncology Chaim Sheba Medical Center, Ramat Gan, Israel|Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy|Presidio Ospedaliero Antonio Perrino - ASL Brindisi, Brindisi, Italy|ASST Lecco - Ospedale Manzoni, Dipartimento Oncologico, Lecco, Italy|Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Direttore Programma Ginecologia Oncologica, Istituto Europeo Oncologia, Milano, Italy|IRCCS Ospedale San Raffaele, U.O. Ginecologia-Ematologia e TMO, Milano, Italy|Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy|Fondazione Policlinico Universitario Gemelli, Roma, Italy|University Saint Anna, Torino, Italy|Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej, Szpital Św. Rafała, Kraków, Poland|Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Oddział Kliniczny Onkologii i Immunoonkologii z Ośrodkiem Dziennym Terapii Onkologicznej, Olsztyn, Poland|Oddział Ginekologii Onkologicznej Katedry i Kliniki Onkologii Uniwersytetu Medycznego w Poznaniu, Poznań, Poland|Servicio de Oncología Médica, Hospital Universitario Quirón Dexeus, Barcelona, Spain|lnstitut Catala d'Oncologia, Hospital Universitario Dr. Josep Trueta, Servicio de Oncologia,, Girona, Spain|Clinica Universidad de Navarra en Madrid, Madrid, Spain|Hospital MD Anderson Cancer Center, Madrid, Spain|Hospital Universitario Ramon y Cajal, Servicio de Oncologia Médica, Madrid, Spain|Hospital 12 de Octubre. Servicio Oncología Médica, Madrid, Spain|Fundació Institut d'Investigació Sanitària Illes Balears - IdISBa, Hospital Universitari Son Espases, Palma De Mallorca, Spain|Gynecological Tumor Center, University Hospital Basel, Basel, Switzerland|IOSI Bellinzona, Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland|Kantonsspital Frauenfeld - Frauenklinik, Frauenfeld, Switzerland|UniversitätsSpital Zürich - Klinik für Gynäkologie, Zürich, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03940196 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 11: | Study 11: |
| NCT Number: NCT03995667 | |
| Title: Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer | NCT Number: NCT03995667 |
| Acronym: | |
| Status: Recruiting | Title: Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer |
| Study Results: No Results Available | |
| Conditions: Extensive Stage Lung Small Cell Carcinoma|Limited Stage Lung Small Cell Carcinoma|Stage I Lung Cancer AJCC v8|Stage IA1 Lung Cancer AJCC v8|Stage IA2 Lung Cancer AJCC v8|Stage IA3 Lung Cancer AJCC v8|Stage IB Lung Cancer AJCC v8|Stage II Lung Cancer AJCC v8|Stage IIA Lung Cancer AJCC v8|Stage IIB Lung Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8 | Acronym: |
| Interventions: Other: Questionnaire Administration|Device: Tumor Treating Fields Therapy | |
| Outcome Measures: Incidence of small cell lung cancer (SCLC) brain metastases at 6 months|Incidence of SCLC brain metastases at 12 months|Overall survival|Incidence of TTfield related adverse events|Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE)|Change in quality of life over time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)|Incidence of SCLC brain metastases | Status: Recruiting |
| Sponsor/Collaborators: OHSU Knight Cancer Institute|NovoCure Ltd.|Oregon Health and Science University | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Extensive Stage Lung Small Cell Carcinoma|Limited Stage Lung Small Cell Carcinoma|Stage I Lung Cancer AJCC v8|Stage IA1 Lung Cancer AJCC v8|Stage IA2 Lung Cancer AJCC v8|Stage IA3 Lung Cancer AJCC v8|Stage IB Lung Cancer AJCC v8|Stage II Lung Cancer AJCC v8|Stage IIA Lung Cancer AJCC v8|Stage IIB Lung Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8 |
| Enrollment: 106 | |
| Funded Bys: Other|Industry | Interventions: Other: Questionnaire Administration|Device: Tumor Treating Fields Therapy |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention | Outcome Measures: Incidence of small cell lung cancer (SCLC) brain metastases at 6 months|Incidence of SCLC brain metastases at 12 months|Overall survival|Incidence of TTfield related adverse events|Incidence of cognitive adverse events (AEs) using Mini Mental State Exam (MMSE)|Change in quality of life over time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)|Incidence of SCLC brain metastases |
| Other IDs: STUDY00018029|NCI-2020-00574 | |
| Start Date: June 11, 2019 | Sponsor/Collaborators: OHSU Knight Cancer Institute|NovoCure Ltd.|Oregon Health and Science University |
| Primary Completion Date: June 20, 2021 | |
| Completion Date: December 30, 2022 | Gender: All |
| First Posted: June 24, 2019 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: December 16, 2020 | |
| Locations: Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States|OHSU Knight Cancer Institute, Portland, Oregon, United States|University of Washington Medical Center, Seattle, Washington, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03995667 | Enrollment: 106 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention |
| | |
| | Other IDs: STUDY00018029|NCI-2020-00574 |
| | |
| | Start Date: June 11, 2019 |
| | |
| | Primary Completion Date: June 20, 2021 |
| | |
| | Completion Date: December 30, 2022 |
| | |
| | First Posted: June 24, 2019 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: December 16, 2020 |
| | |
| | Locations: Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States|OHSU Knight Cancer Institute, Portland, Oregon, United States|University of Washington Medical Center, Seattle, Washington, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03995667 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 12: | Study 12: |
| NCT Number: NCT01971281 | |
| Title: Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA) | NCT Number: NCT01971281 |
| Acronym: | |
| Status: Unknown status | Title: Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA) |
| Study Results: No Results Available | |
| Conditions: Pancreatic Adenocarcinoma | Acronym: |
| Interventions: Device: NovoTTF-100L|Drug: Gemcitabine|Drug: nab-Paclitaxel | |
| Outcome Measures: Adverse Events Severity and Frequency|Feasibility based on compliance with TTFields therapy|Progression Free Survival|Overall Survival|1 Year Survival Rate|6 Month Progression-Free Survival Rate|Overall Response Rate based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1. | Status: Unknown status |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1|Phase 2 | Conditions: Pancreatic Adenocarcinoma |
| Enrollment: 40 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L|Drug: Gemcitabine|Drug: nab-Paclitaxel |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Adverse Events Severity and Frequency|Feasibility based on compliance with TTFields therapy|Progression Free Survival|Overall Survival|1 Year Survival Rate|6 Month Progression-Free Survival Rate|Overall Response Rate based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1. |
| Other IDs: EF-20 | |
| Start Date: November 2013 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: December 2017 | |
| Completion Date: December 2017 | Gender: All |
| First Posted: October 29, 2013 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 13, 2017 | |
| Locations: Hospital General Universitario de Elche, Elche, Spain|Hospital 12 de Octubre, Madrid, Spain|Ramon Y Cajal, Madrid, Spain|Hospital Universitario Carlos Haya, Malaga, Spain|Hospital Universitario Santander, Santander, Spain|HFR-Hopital Cantonal, Freiburg, Switzerland | Phases: Phase 1|Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT01971281 | Enrollment: 40 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-20 |
| | |
| | Start Date: November 2013 |
| | |
| | Primary Completion Date: December 2017 |
| | |
| | Completion Date: December 2017 |
| | |
| | First Posted: October 29, 2013 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 13, 2017 |
| | |
| | Locations: Hospital General Universitario de Elche, Elche, Spain|Hospital 12 de Octubre, Madrid, Spain|Ramon Y Cajal, Madrid, Spain|Hospital Universitario Carlos Haya, Malaga, Spain|Hospital Universitario Santander, Santander, Spain|HFR-Hopital Cantonal, Freiburg, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT01971281 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 13: | Study 13: |
| NCT Number: NCT04281576 | |
| Title: Effect of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Chemotherapy as First Line Treatment of Unresectable Gastroesophageal Junction or Gastric Adenocarcinoma | NCT Number: NCT04281576 |
| Acronym: | |
| Status: Recruiting | Title: Effect of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Chemotherapy as First Line Treatment of Unresectable Gastroesophageal Junction or Gastric Adenocarcinoma |
| Study Results: No Results Available | |
| Conditions: Gastric Cancer|GastroEsophageal Cancer | Acronym: |
| Interventions: Device: NovoTTF-100L(P)|Drug: Oxaliplatin|Drug: Capecitabine|Drug: Trastuzumab | |
| Outcome Measures: Objective response rate|Progression-free survival|Overall survival|Disease control rate|Time to progression|Duration of response|12 month overall survival rate|Severity and frequency of adverse events | Status: Recruiting |
| Sponsor/Collaborators: NovoCure GmbH|Zai Lab (Shanghai) Co., Ltd.|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Gastric Cancer|GastroEsophageal Cancer |
| Enrollment: 28 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L(P)|Drug: Oxaliplatin|Drug: Capecitabine|Drug: Trastuzumab |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Objective response rate|Progression-free survival|Overall survival|Disease control rate|Time to progression|Duration of response|12 month overall survival rate|Severity and frequency of adverse events |
| Other IDs: EF-31 / ZL-8301-001 | |
| Start Date: December 19, 2019 | Sponsor/Collaborators: NovoCure GmbH|Zai Lab (Shanghai) Co., Ltd.|NovoCure Ltd. |
| Primary Completion Date: September 2021 | |
| Completion Date: September 2021 | Gender: All |
| First Posted: February 24, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: June 25, 2020 | |
| Locations: Queen Mary Hospital, Hong Kong, Hong Kong | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04281576 | Enrollment: 28 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-31 / ZL-8301-001 |
| | |
| | Start Date: December 19, 2019 |
| | |
| | Primary Completion Date: September 2021 |
| | |
| | Completion Date: September 2021 |
| | |
| | First Posted: February 24, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: June 25, 2020 |
| | |
| | Locations: Queen Mary Hospital, Hong Kong, Hong Kong |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04281576 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 14: | Study 14: |
| NCT Number: NCT03405792 | |
| Title: Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP) | NCT Number: NCT03405792 |
| Acronym: 2-THE-TOP | |
| Status: Recruiting | Title: Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP) |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Glioblastoma, WHO Grade IV | Acronym: 2-THE-TOP |
| Interventions: Drug: Temozolomide (TMZ)|Device: Optune System|Drug: Pembrolizumab | |
| Outcome Measures: Progression-free survival between the groups|Number of adverse events|Overall Survival (OS)|Augmentation of TTFields-initiated glioma-specific immune reaction by pembrolizumab | Status: Recruiting |
| Sponsor/Collaborators: University of Florida|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years to 80 Years (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma|Glioblastoma, WHO Grade IV |
| Enrollment: 32 | |
| Funded Bys: Other|Industry | Interventions: Drug: Temozolomide (TMZ)|Device: Optune System|Drug: Pembrolizumab |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Progression-free survival between the groups|Number of adverse events|Overall Survival (OS)|Augmentation of TTFields-initiated glioma-specific immune reaction by pembrolizumab |
| Other IDs: IRB201702270|OCR16397 | |
| Start Date: February 23, 2018 | Sponsor/Collaborators: University of Florida|NovoCure Ltd. |
| Primary Completion Date: February 2023 | |
| Completion Date: February 2023 | Gender: All |
| First Posted: January 23, 2018 | |
| Results First Posted: | Age: 18 Years to 80 Years (Adult, Older Adult) |
| Last Update Posted: February 9, 2021 | |
| Locations: University of Florida Health, Gainesville, Florida, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03405792 | Enrollment: 32 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: IRB201702270|OCR16397 |
| | |
| | Start Date: February 23, 2018 |
| | |
| | Primary Completion Date: February 2023 |
| | |
| | Completion Date: February 2023 |
| | |
| | First Posted: January 23, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: February 9, 2021 |
| | |
| | Locations: University of Florida Health, Gainesville, Florida, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03405792 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 15: | Study 15: |
| NCT Number: NCT04218019 | |
| Title: Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation | NCT Number: NCT04218019 |
| Acronym: GERAS | |
| Status: Not yet recruiting | Title: Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation |
| Study Results: No Results Available | |
| Conditions: Newly Diagnosed Glioblastoma in Patients ≥70 Years | Acronym: GERAS |
| Interventions: Device: TTFields | |
| Outcome Measures: Safely conducted therapy rate (SCTR)|Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.|Progression-free survival|The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy. | Status: Not yet recruiting |
| Sponsor/Collaborators: Juergen Debus|University Hospital Heidelberg | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Newly Diagnosed Glioblastoma in Patients ≥70 Years |
| Enrollment: 68 | |
| Funded Bys: Other | Interventions: Device: TTFields |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Safely conducted therapy rate (SCTR)|Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.|Progression-free survival|The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy. |
| Other IDs: GERAS | |
| Start Date: August 1, 2021 | Sponsor/Collaborators: Juergen Debus|University Hospital Heidelberg |
| Primary Completion Date: February 1, 2022 | |
| Completion Date: February 1, 2023 | Gender: All |
| First Posted: January 6, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 11, 2020 | |
| Locations: University Hospital of Heidelberg, Radiation Oncology, Heidelberg, Germany | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04218019 | Enrollment: 68 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: GERAS |
| | |
| | Start Date: August 1, 2021 |
| | |
| | Primary Completion Date: February 1, 2022 |
| | |
| | Completion Date: February 1, 2023 |
| | |
| | First Posted: January 6, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 11, 2020 |
| | |
| | Locations: University Hospital of Heidelberg, Radiation Oncology, Heidelberg, Germany |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04218019 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 16: | Study 16: |
| NCT Number: NCT03906448 | |
| Title: FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma | NCT Number: NCT03906448 |
| Acronym: FORWARD | |
| Status: Terminated | Title: FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma |
| Study Results: No Results Available | |
| Conditions: Astrocytoma, Grade II|Astrocytoma, Grade III | Acronym: FORWARD |
| Interventions: Combination Product: TTFields with adjuvant temozolomide | |
| Outcome Measures: Overall Survival | Status: Terminated |
| Sponsor/Collaborators: University of Florida|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years to 99 Years (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Astrocytoma, Grade II|Astrocytoma, Grade III |
| Enrollment: 2 | |
| Funded Bys: Other|Industry | Interventions: Combination Product: TTFields with adjuvant temozolomide |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall Survival |
| Other IDs: IRB201800600|OCR17711 | |
| Start Date: May 20, 2019 | Sponsor/Collaborators: University of Florida|NovoCure Ltd. |
| Primary Completion Date: June 8, 2020 | |
| Completion Date: June 8, 2020 | Gender: All |
| First Posted: April 8, 2019 | |
| Results First Posted: | Age: 18 Years to 99 Years (Adult, Older Adult) |
| Last Update Posted: June 17, 2020 | |
| Locations: UF Health at the University of Florida, Gainesville, Florida, United States|USF Health Morsani College of Medicine-Moffitt Cancer Center, Tampa, Florida, United States|Henry Ford Health System, Detroit, Michigan, United States|Brown University-Rhode Island Hospital, Providence, Rhode Island, United States|The University of Texas Health Science Center at Houston, Houston, Texas, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03906448 | Enrollment: 2 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: IRB201800600|OCR17711 |
| | |
| | Start Date: May 20, 2019 |
| | |
| | Primary Completion Date: June 8, 2020 |
| | |
| | Completion Date: June 8, 2020 |
| | |
| | First Posted: April 8, 2019 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: June 17, 2020 |
| | |
| | Locations: UF Health at the University of Florida, Gainesville, Florida, United States|USF Health Morsani College of Medicine-Moffitt Cancer Center, Tampa, Florida, United States|Henry Ford Health System, Detroit, Michigan, United States|Brown University-Rhode Island Hospital, Providence, Rhode Island, United States|The University of Texas Health Science Center at Houston, Houston, Texas, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03906448 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 17: | Study 17: |
| NCT Number: NCT04221503 | |
| Title: Niraparib/TTFields in GBM | NCT Number: NCT04221503 |
| Acronym: | |
| Status: Recruiting | Title: Niraparib/TTFields in GBM |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Recurrent Glioblastoma|GBM | Acronym: |
| Interventions: Drug: Niraparib|Device: Optune|Procedure: Planned surgical resection | |
| Outcome Measures: Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria.|Number of AEs (Adverse Events)|Duration of disease control.|Objective radiographic response (ORR)|Progression-free survival (PFS)|Overall survival (OS) | Status: Recruiting |
| Sponsor/Collaborators: University of Pennsylvania|Tesaro, Inc.|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma|Recurrent Glioblastoma|GBM |
| Enrollment: 30 | |
| Funded Bys: Other|Industry | Interventions: Drug: Niraparib|Device: Optune|Procedure: Planned surgical resection |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria.|Number of AEs (Adverse Events)|Duration of disease control.|Objective radiographic response (ORR)|Progression-free survival (PFS)|Overall survival (OS) |
| Other IDs: 03319 | |
| Start Date: December 30, 2019 | Sponsor/Collaborators: University of Pennsylvania|Tesaro, Inc.|NovoCure Ltd. |
| Primary Completion Date: December 2025 | |
| Completion Date: December 2025 | Gender: All |
| First Posted: January 9, 2020 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: July 2, 2020 | |
| Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04221503 | Enrollment: 30 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 03319 |
| | |
| | Start Date: December 30, 2019 |
| | |
| | Primary Completion Date: December 2025 |
| | |
| | Completion Date: December 2025 |
| | |
| | First Posted: January 9, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: July 2, 2020 |
| | |
| | Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04221503 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 18: | Study 18: |
| NCT Number: NCT02831959 | |
| Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fileds (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC). | NCT Number: NCT02831959 |
| Acronym: | |
| Status: Recruiting | Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fileds (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC). |
| Study Results: No Results Available | |
| Conditions: Brain Metastases From Non-small Cell Lung Cancer (NSCLC) | Acronym: |
| Interventions: Device: NovoTTF-100M device|Other: Best Standard of Care | |
| Outcome Measures: Time to intracranial progression|Time to neurocognitive failure|Overall survival|Radiological response in the brain|Time to second intracranial progression|Time to first and second intracranial progression evaluated in two cohorts, 1-4 brain metastases and 5-10 brain metastases.|Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months|Time to distant progression|Rate of decline in cognitive function at 2, 4, 6, 8, 10, 12 months|Neurocognitive failure-free survival|Quality of Life using the EORTC QLQ C30 with BN20 addendum|Toxicity during NovoTTF-100M treatment based on incidence and severity of treatment emergent adverse events as evaluated using the CTCAE version 4.0 | Status: Recruiting |
| Sponsor/Collaborators: NovoCure GmbH|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 3 | Conditions: Brain Metastases From Non-small Cell Lung Cancer (NSCLC) |
| Enrollment: 270 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100M device|Other: Best Standard of Care |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Time to intracranial progression|Time to neurocognitive failure|Overall survival|Radiological response in the brain|Time to second intracranial progression|Time to first and second intracranial progression evaluated in two cohorts, 1-4 brain metastases and 5-10 brain metastases.|Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months|Time to distant progression|Rate of decline in cognitive function at 2, 4, 6, 8, 10, 12 months|Neurocognitive failure-free survival|Quality of Life using the EORTC QLQ C30 with BN20 addendum|Toxicity during NovoTTF-100M treatment based on incidence and severity of treatment emergent adverse events as evaluated using the CTCAE version 4.0 |
| Other IDs: EF-25 METIS | |
| Start Date: July 2016 | Sponsor/Collaborators: NovoCure GmbH|NovoCure Ltd. |
| Primary Completion Date: September 2022 | |
| Completion Date: September 2022 | Gender: All |
| First Posted: July 13, 2016 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: January 6, 2021 | |
| Locations: University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States|Mayo Clinic Phoenix, Phoenix, Arizona, United States|MemorialCare Cancer Institute, Long Beach, California, United States|The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange, Orange, California, United States|Kaiser Permanente Redwood City, Redwood City, California, United States|Dignity Health - Mercy Cancer Centers, Sacramento, California, United States|Kaiser Permanente - Sacramento, Sacramento, California, United States|Sharp HealthCare, San Diego, California, United States|University of California, San Francisco, California, United States|Mayo Clinic, Jacksonville, Florida, United States|Miami Cancer Institute, Miami, Florida, United States|UF Health Cancer Center, Orlando, Florida, United States|BRCR Medical Center INC, Plantation, Florida, United States|Piedmont Brain Tumor Center, Atlanta, Georgia, United States|CDH-Delnor Health System, Warrenville, Illinois, United States|Ochsner Health System, New Orleans, Louisiana, United States|Willis-Knighton Cancer Center, Shreveport, Louisiana, United States|University of Maryland, Baltimore, Maryland, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|John Nasseff Neuroscience Institute ANW Brain Tumor Center, Minneapolis, Minnesota, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Ellis Fischel Cancer Center, University of Missouri Healthcare, Columbia, Missouri, United States|Oncology Research Mercy Research, Saint Louis, Missouri, United States|Renown Regional Medical Center, Reno, Nevada, United States|MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States|UNC - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States|Vidant Medical Center, Greenville, North Carolina, United States|Cleveland Clinic, Cleveland, Ohio, United States|Providence St. Vincent Medical Center, Portland, Oregon, United States|Geisinger Medical Center, Danville, Pennsylvania, United States|Rhode Island Hospital, Providence, Rhode Island, United States|West Cancer Center, Germantown, Tennessee, United States|Houston Methodist Hospital, Houston, Texas, United States|Texas Oncology, McKinney, Texas, United States|Texas Oncology, Plano, Texas, United States|University of Washington Medical Center, Seattle, Washington, United States|Medizinische Universität Innsbruck, Innsbruck, Austria|UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology, Sofia, Bulgaria|University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology, Sofia, Bulgaria|Cancercare Manitoba, Winnipeg, Manitoba, Canada|Notre-Dame Hospital CHUM, Montreal, Quebec, Canada|Jewish General Hospital, Montreal, Quebec, Canada|Le CIUSSS de I'Est-de-L'ile de Montreal, Montréal, Quebec, Canada|Radiochirugia Zagreb, Sveta Nedelja, Croatia|University Hospital Lille, Lille, France|Clairval Hospital Center, Marseille, France|Hopital Pitié-Salpétriere, Paris, France|Universitätsklinikum Düsseldorf, Düsseldorf, Germany|Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie, Frankfurt am main, Germany|Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie, Halle (Saale), Germany|Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County, Szolnok, Hungary|Rambam Medical Center, Haifa, Israel|Hadassah Medical Organization, Jerusalem, Israel|Rabin Medical Center, Petah Tikva, Israel|Sheba Medical Center, Ramat Gan, Israel|Sourasky Medical Center, Tel Aviv, Israel|A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità, Avellino, Italy|Azienda Socio Sanitaria Territoriale di Lecco, Lecco, Italy|University Hospital of Messina AOU Policlinico "G. Martino", Messina, Italy|Marek Harat Private Practice, Neurosurgery and Radiation Oncology, Bydgoszcz, Poland|University Clinical Center, Gdańsk, Poland|Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznań, Poland|Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia, Belgrad, Serbia|Catalan Institute of Oncology, Barcelona, Spain|Clinica Universidad de Navarra, Pamplona, Spain | Phases: Phase 3 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02831959 | Enrollment: 270 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-25 METIS |
| | |
| | Start Date: July 2016 |
| | |
| | Primary Completion Date: September 2022 |
| | |
| | Completion Date: September 2022 |
| | |
| | First Posted: July 13, 2016 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: January 6, 2021 |
| | |
| | Locations: University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States|Mayo Clinic Phoenix, Phoenix, Arizona, United States|MemorialCare Cancer Institute, Long Beach, California, United States|The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange, Orange, California, United States|Kaiser Permanente Redwood City, Redwood City, California, United States|Dignity Health - Mercy Cancer Centers, Sacramento, California, United States|Kaiser Permanente - Sacramento, Sacramento, California, United States|Sharp HealthCare, San Diego, California, United States|University of California, San Francisco, California, United States|Mayo Clinic, Jacksonville, Florida, United States|Miami Cancer Institute, Miami, Florida, United States|UF Health Cancer Center, Orlando, Florida, United States|BRCR Medical Center INC, Plantation, Florida, United States|Piedmont Brain Tumor Center, Atlanta, Georgia, United States|CDH-Delnor Health System, Warrenville, Illinois, United States|Ochsner Health System, New Orleans, Louisiana, United States|Willis-Knighton Cancer Center, Shreveport, Louisiana, United States|University of Maryland, Baltimore, Maryland, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|John Nasseff Neuroscience Institute ANW Brain Tumor Center, Minneapolis, Minnesota, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Ellis Fischel Cancer Center, University of Missouri Healthcare, Columbia, Missouri, United States|Oncology Research Mercy Research, Saint Louis, Missouri, United States|Renown Regional Medical Center, Reno, Nevada, United States|MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States|UNC - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States|Vidant Medical Center, Greenville, North Carolina, United States|Cleveland Clinic, Cleveland, Ohio, United States|Providence St. Vincent Medical Center, Portland, Oregon, United States|Geisinger Medical Center, Danville, Pennsylvania, United States|Rhode Island Hospital, Providence, Rhode Island, United States|West Cancer Center, Germantown, Tennessee, United States|Houston Methodist Hospital, Houston, Texas, United States|Texas Oncology, McKinney, Texas, United States|Texas Oncology, Plano, Texas, United States|University of Washington Medical Center, Seattle, Washington, United States|Medizinische Universität Innsbruck, Innsbruck, Austria|UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology, Sofia, Bulgaria|University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology, Sofia, Bulgaria|Cancercare Manitoba, Winnipeg, Manitoba, Canada|Notre-Dame Hospital CHUM, Montreal, Quebec, Canada|Jewish General Hospital, Montreal, Quebec, Canada|Le CIUSSS de I'Est-de-L'ile de Montreal, Montréal, Quebec, Canada|Radiochirugia Zagreb, Sveta Nedelja, Croatia|University Hospital Lille, Lille, France|Clairval Hospital Center, Marseille, France|Hopital Pitié-Salpétriere, Paris, France|Universitätsklinikum Düsseldorf, Düsseldorf, Germany|Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie, Frankfurt am main, Germany|Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie, Halle (Saale), Germany|Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County, Szolnok, Hungary|Rambam Medical Center, Haifa, Israel|Hadassah Medical Organization, Jerusalem, Israel|Rabin Medical Center, Petah Tikva, Israel|Sheba Medical Center, Ramat Gan, Israel|Sourasky Medical Center, Tel Aviv, Israel|A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità, Avellino, Italy|Azienda Socio Sanitaria Territoriale di Lecco, Lecco, Italy|University Hospital of Messina AOU Policlinico "G. Martino", Messina, Italy|Marek Harat Private Practice, Neurosurgery and Radiation Oncology, Bydgoszcz, Poland|University Clinical Center, Gdańsk, Poland|Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznań, Poland|Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia, Belgrad, Serbia|Catalan Institute of Oncology, Barcelona, Spain|Clinica Universidad de Navarra, Pamplona, Spain |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02831959 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 19: | Study 19: |
| NCT Number: NCT02663271 | |
| Title: TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma | NCT Number: NCT02663271 |
| Acronym: | |
| Status: Recruiting | Title: TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme|Glioblastoma|Malignant Glioma|GBM | Acronym: |
| Interventions: Drug: Bevacizumab|Device: Optune|Other: Brain MRI|Other: Quality of Life Questionnaires | |
| Outcome Measures: Progression-free survival between the groups|Number of adverse events|Karnofsky Performance Scale|Mini-Mental Status Exam|Response Assessment in Neuro-Oncology (RANO) Measurement Form | Status: Recruiting |
| Sponsor/Collaborators: University of Florida|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma Multiforme|Glioblastoma|Malignant Glioma|GBM |
| Enrollment: 18 | |
| Funded Bys: Other|Industry | Interventions: Drug: Bevacizumab|Device: Optune|Other: Brain MRI|Other: Quality of Life Questionnaires |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Progression-free survival between the groups|Number of adverse events|Karnofsky Performance Scale|Mini-Mental Status Exam|Response Assessment in Neuro-Oncology (RANO) Measurement Form |
| Other IDs: IRB201600074|OCR14874 | |
| Start Date: August 2016 | Sponsor/Collaborators: University of Florida|NovoCure Ltd. |
| Primary Completion Date: March 15, 2022 | |
| Completion Date: March 15, 2022 | Gender: All |
| First Posted: January 26, 2016 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: November 3, 2020 | |
| Locations: University of Florida, Gainesville, Florida, United States|Washington University, Saint Louis, Missouri, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02663271 | Enrollment: 18 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: IRB201600074|OCR14874 |
| | |
| | Start Date: August 2016 |
| | |
| | Primary Completion Date: March 15, 2022 |
| | |
| | Completion Date: March 15, 2022 |
| | |
| | First Posted: January 26, 2016 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: November 3, 2020 |
| | |
| | Locations: University of Florida, Gainesville, Florida, United States|Washington University, Saint Louis, Missouri, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02663271 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 20: | Study 20: |
| NCT Number: NCT02743078 | |
| Title: Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma | NCT Number: NCT02743078 |
| Acronym: | |
| Status: Terminated | Title: Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma |
| Study Results: Has Results | |
| Conditions: Glioblastoma|Glioma|Gliosarcoma | Acronym: |
| Interventions: Drug: Bevacizumab|Device: TTFields Therapy | |
| Outcome Measures: Overall Survival at 6 Months|Overall Survival (OS)|Progression-Free Survival|Number of Participants With Partial or Complete Response|Number of Participants With Grade 3+ Treatment-related Adverse Events | Status: Terminated |
| Sponsor/Collaborators: RTOG Foundation, Inc.|NovoCure Ltd. | |
| Gender: All | Study Results: Has Results |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma|Glioma|Gliosarcoma |
| Enrollment: 3 | |
| Funded Bys: Other|Industry | Interventions: Drug: Bevacizumab|Device: TTFields Therapy |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall Survival at 6 Months|Overall Survival (OS)|Progression-Free Survival|Number of Participants With Partial or Complete Response|Number of Participants With Grade 3+ Treatment-related Adverse Events |
| Other IDs: RTOG 3503|RF 3503 | |
| Start Date: May 9, 2017 | Sponsor/Collaborators: RTOG Foundation, Inc.|NovoCure Ltd. |
| Primary Completion Date: October 15, 2019 | |
| Completion Date: October 15, 2019 | Gender: All |
| First Posted: April 19, 2016 | |
| Results First Posted: November 17, 2020 | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: November 17, 2020 | |
| Locations: University of California, San Diego, La Jolla, California, United States|University of California Irvine, Chao Family Comprehensive Cancer Center, Orange, California, United States|Miami Cancer Institute at Baptist Health, Miami, Florida, United States|UF Health Cancer Center at Orlando Health, Orlando, Florida, United States|Emory University, Atlanta, Georgia, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|University of Rochester, Rochester, New York, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States | Phases: Phase 2 |
| Study Documents: "Study Protocol and Statistical Analysis Plan", https://ClinicalTrials.gov/ProvidedDocs/78/NCT02743078/Prot_SAP_000.pdf|"Informed Consent Form", https://ClinicalTrials.gov/ProvidedDocs/78/NCT02743078/ICF_001.pdf | |
| URL: https://ClinicalTrials.gov/show/NCT02743078 | Enrollment: 3 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: RTOG 3503|RF 3503 |
| | |
| | Start Date: May 9, 2017 |
| | |
| | Primary Completion Date: October 15, 2019 |
| | |
| | Completion Date: October 15, 2019 |
| | |
| | First Posted: April 19, 2016 |
| | |
| | Results First Posted: November 17, 2020 |
| | |
| | Last Update Posted: November 17, 2020 |
| | |
| | Locations: University of California, San Diego, La Jolla, California, United States|University of California Irvine, Chao Family Comprehensive Cancer Center, Orange, California, United States|Miami Cancer Institute at Baptist Health, Miami, Florida, United States|UF Health Cancer Center at Orlando Health, Orlando, Florida, United States|Emory University, Atlanta, Georgia, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|University of Rochester, Rochester, New York, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States |
| | |
| | Study Documents: "Study Protocol and Statistical Analysis Plan", https://ClinicalTrials.gov/ProvidedDocs/78/NCT02743078/Prot_SAP_000.pdf|"Informed Consent Form", https://ClinicalTrials.gov/ProvidedDocs/78/NCT02743078/ICF_001.pdf |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02743078 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 21: | Study 21: |
| NCT Number: NCT02244502 | |
| Title: Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE) | NCT Number: NCT02244502 |
| Acronym: | |
| Status: Unknown status | Title: Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE) |
| Study Results: No Results Available | |
| Conditions: Ovarian Carcinoma | Acronym: |
| Interventions: Device: NovoTTF-100L(O)|Drug: Paclitaxel | |
| Outcome Measures: Adverse Events Severity and Frequency|Number of patients prematurely discontinuing TTFields due to Skin Toxicity|Progression Free Survival|Overall Survival|1 Year Survival Rate|Overall Radiological Response Rate and Duration of Response|CA-125 Response Rate and Duration of Response|Patients' compliance with TTFields Therapy | Status: Unknown status |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: Female | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1|Phase 2 | Conditions: Ovarian Carcinoma |
| Enrollment: 31 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L(O)|Drug: Paclitaxel |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Adverse Events Severity and Frequency|Number of patients prematurely discontinuing TTFields due to Skin Toxicity|Progression Free Survival|Overall Survival|1 Year Survival Rate|Overall Radiological Response Rate and Duration of Response|CA-125 Response Rate and Duration of Response|Patients' compliance with TTFields Therapy |
| Other IDs: EF-22 | |
| Start Date: September 2014 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: December 2016 | |
| Completion Date: December 2016 | Gender: Female |
| First Posted: September 19, 2014 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 21, 2016 | |
| Locations: Leuven, Belgium|Charité - Universitätsmedizin Berlin, Berlin, Germany|Hospitale Universitario 12 de Octubre, Madrid, Spain|Ospedale San Giovanni, Bellinzona, Switzerland|Kantonsspital Graubünden, Chur, Switzerland | Phases: Phase 1|Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02244502 | Enrollment: 31 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-22 |
| | |
| | Start Date: September 2014 |
| | |
| | Primary Completion Date: December 2016 |
| | |
| | Completion Date: December 2016 |
| | |
| | First Posted: September 19, 2014 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 21, 2016 |
| | |
| | Locations: Leuven, Belgium|Charité - Universitätsmedizin Berlin, Berlin, Germany|Hospitale Universitario 12 de Octubre, Madrid, Spain|Ospedale San Giovanni, Bellinzona, Switzerland|Kantonsspital Graubünden, Chur, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02244502 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 22: | Study 22: |
| NCT Number: NCT03033992 | |
| Title: Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma | NCT Number: NCT03033992 |
| Acronym: | |
| Status: Recruiting | Title: Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma |
| Study Results: No Results Available | |
| Conditions: Malignant Glioma|Ependymoma | Acronym: |
| Interventions: Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields) | |
| Outcome Measures: The feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.|The Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.|The Response Rate|The Event-Free Survival|The association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study.|The association between the Optune device usage and the health-related quality of life of children and families undergoing this therapy.|The association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS. | Status: Recruiting |
| Sponsor/Collaborators: Pediatric Brain Tumor Consortium|National Cancer Institute (NCI) | |
| Gender: All | Study Results: No Results Available |
| Age: 5 Years to 21 Years (Child, Adult) | |
| Phases: Not Applicable | Conditions: Malignant Glioma|Ependymoma |
| Enrollment: 25 | |
| Funded Bys: Other|NIH | Interventions: Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields) |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: The feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.|The Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.|The Response Rate|The Event-Free Survival|The association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study.|The association between the Optune device usage and the health-related quality of life of children and families undergoing this therapy.|The association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS. |
| Other IDs: PBTC-048|5UM1CA081457 | |
| Start Date: April 4, 2017 | Sponsor/Collaborators: Pediatric Brain Tumor Consortium|National Cancer Institute (NCI) |
| Primary Completion Date: April 2021 | |
| Completion Date: April 2021 | Gender: All |
| First Posted: January 27, 2017 | |
| Results First Posted: | Age: 5 Years to 21 Years (Child, Adult) |
| Last Update Posted: February 15, 2021 | |
| Locations: Children's Hospital Los Angeles, Los Angeles, California, United States|Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States|Children's National Medical Center, Washington, District of Columbia, United States|Stewart Goldman, Chicago, Illinois, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States|Children Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States|Saint Jude Children's Research Hospital, Memphis, Tennessee, United States|Baylor College of Medicine, Houston, Texas, United States | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03033992 | Enrollment: 25 |
| | |
| | Funded Bys: Other|NIH |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: PBTC-048|5UM1CA081457 |
| | |
| | Start Date: April 4, 2017 |
| | |
| | Primary Completion Date: April 2021 |
| | |
| | Completion Date: April 2021 |
| | |
| | First Posted: January 27, 2017 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: February 15, 2021 |
| | |
| | Locations: Children's Hospital Los Angeles, Los Angeles, California, United States|Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California, United States|Children's National Medical Center, Washington, District of Columbia, United States|Stewart Goldman, Chicago, Illinois, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States|Children Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States|Saint Jude Children's Research Hospital, Memphis, Tennessee, United States|Baylor College of Medicine, Houston, Texas, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03033992 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 23: | Study 23: |
| NCT Number: NCT04221061 | |
| Title: A Pilot Study Evaluating in Vivo PARP-1 Expression with18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Glioblastoma | NCT Number: NCT04221061 |
| Acronym: | |
| Status: Recruiting | Title: A Pilot Study Evaluating in Vivo PARP-1 Expression with18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Drug: 18F-FluorThanatrace | |
| Outcome Measures: Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy.|Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness". | Status: Recruiting |
| Sponsor/Collaborators: University of Pennsylvania | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Early Phase 1 | Conditions: Glioblastoma |
| Enrollment: 12 | |
| Funded Bys: Other | Interventions: Drug: 18F-FluorThanatrace |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Diagnostic | Outcome Measures: Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy.|Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness". |
| Other IDs: 833963 | |
| Start Date: February 20, 2020 | Sponsor/Collaborators: University of Pennsylvania |
| Primary Completion Date: December 2, 2021 | |
| Completion Date: December 2, 2022 | Gender: All |
| First Posted: January 9, 2020 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: February 12, 2021 | |
| Locations: University of Pennsylvania, Philadelphia, Pennsylvania, United States | Phases: Early Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04221061 | Enrollment: 12 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Diagnostic |
| | |
| | Other IDs: 833963 |
| | |
| | Start Date: February 20, 2020 |
| | |
| | Primary Completion Date: December 2, 2021 |
| | |
| | Completion Date: December 2, 2022 |
| | |
| | First Posted: January 9, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: February 12, 2021 |
| | |
| | Locations: University of Pennsylvania, Philadelphia, Pennsylvania, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04221061 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 24: | Study 24: |
| NCT Number: NCT03780569 | |
| Title: TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM | NCT Number: NCT03780569 |
| Acronym: | |
| Status: Unknown status | Title: TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme | Acronym: |
| Interventions: Device: NovoTTF-200A|Radiation: Radiotherapy|Drug: Temozolomide | |
| Outcome Measures: Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.|Progression free survival|Overall survival|Adverse events, severity and frequency | Status: Unknown status |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Glioblastoma Multiforme |
| Enrollment: 10 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-200A|Radiation: Radiotherapy|Drug: Temozolomide |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.|Progression free survival|Overall survival|Adverse events, severity and frequency |
| Other IDs: ICH-1 | |
| Start Date: April 27, 2017 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: January 2019 | |
| Completion Date: January 2019 | Gender: All |
| First Posted: December 19, 2018 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: December 20, 2018 | |
| Locations: Tel Aviv Sourasky Medical Center, Tel Aviv, Israel | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03780569 | Enrollment: 10 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: ICH-1 |
| | |
| | Start Date: April 27, 2017 |
| | |
| | Primary Completion Date: January 2019 |
| | |
| | Completion Date: January 2019 |
| | |
| | First Posted: December 19, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: December 20, 2018 |
| | |
| | Locations: Tel Aviv Sourasky Medical Center, Tel Aviv, Israel |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03780569 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 25: | Study 25: |
| NCT Number: NCT01755624 | |
| Title: Effect of TTFields (150kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment (COMET) | NCT Number: NCT01755624 |
| Acronym: | |
| Status: Unknown status | Title: Effect of TTFields (150kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment (COMET) |
| Study Results: No Results Available | |
| Conditions: 1-5 Brain Metastases From Non-Small Cell Lung Cancer | Acronym: |
| Interventions: Device: NovoTTF-100A device|Other: Best Standard of Care | |
| Outcome Measures: Time to Local and Distant Progression in The Brain|Overall Survival|6-Month Disease Control Rate in The Brain|Neurocognitive Function (MMSE and HVLT)|Quality of life (QLQ-C30 and BN-20)|Overall (systemic) Progression-Free Survival (RECIST Criteria)|Adverse Events Severity and Frequency | Status: Unknown status |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: 1-5 Brain Metastases From Non-Small Cell Lung Cancer |
| Enrollment: 18 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100A device|Other: Best Standard of Care |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Time to Local and Distant Progression in The Brain|Overall Survival|6-Month Disease Control Rate in The Brain|Neurocognitive Function (MMSE and HVLT)|Quality of life (QLQ-C30 and BN-20)|Overall (systemic) Progression-Free Survival (RECIST Criteria)|Adverse Events Severity and Frequency |
| Other IDs: EF-21 | |
| Start Date: January 2013 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: July 2017 | |
| Completion Date: July 2017 | Gender: All |
| First Posted: December 24, 2012 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 21, 2016 | |
| Locations: Na Homolce Hospital, Prague, Czech Republic|Hopital Neurologique Pierre Wertheimer, Lyon, France|Centre Paul Strauss, Strasbourg, France|Ospedale Lecco, Lecco, Italy|Medical University of Gdańsk, Gdańsk, Poland|Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan, Poland|ICO L'Hospitalet - Hospital Duran i Reynals, Barcelona, Spain | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT01755624 | Enrollment: 18 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-21 |
| | |
| | Start Date: January 2013 |
| | |
| | Primary Completion Date: July 2017 |
| | |
| | Completion Date: July 2017 |
| | |
| | First Posted: December 24, 2012 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 21, 2016 |
| | |
| | Locations: Na Homolce Hospital, Prague, Czech Republic|Hopital Neurologique Pierre Wertheimer, Lyon, France|Centre Paul Strauss, Strasbourg, France|Ospedale Lecco, Lecco, Italy|Medical University of Gdańsk, Gdańsk, Poland|Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan, Poland|ICO L'Hospitalet - Hospital Duran i Reynals, Barcelona, Spain |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT01755624 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 26: | Study 26: |
| NCT Number: NCT03223103 | |
| Title: Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma | NCT Number: NCT03223103 |
| Acronym: | |
| Status: Recruiting | Title: Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Drug: Poly-ICLC|Device: Tumor Treating Fields|Biological: Peptides | |
| Outcome Measures: Dose-limiting toxicities (DLT)|Toxicity grading using CTCAE scale|The percent Progression Free Survival (PFS)|Overall Survival (OS) Rate|Overall Response Rate | Status: Recruiting |
| Sponsor/Collaborators: Adilia Hormigo|NovoCure Ltd.|Icahn School of Medicine at Mount Sinai | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma |
| Enrollment: 20 | |
| Funded Bys: Other|Industry | Interventions: Drug: Poly-ICLC|Device: Tumor Treating Fields|Biological: Peptides |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Dose-limiting toxicities (DLT)|Toxicity grading using CTCAE scale|The percent Progression Free Survival (PFS)|Overall Survival (OS) Rate|Overall Response Rate |
| Other IDs: GCO 17-0566|16-089 | |
| Start Date: March 1, 2018 | Sponsor/Collaborators: Adilia Hormigo|NovoCure Ltd.|Icahn School of Medicine at Mount Sinai |
| Primary Completion Date: May 2023 | |
| Completion Date: May 2023 | Gender: All |
| First Posted: July 19, 2017 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 2, 2020 | |
| Locations: Icahn School of Medicine at Mount Sinai, New York, New York, United States | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03223103 | Enrollment: 20 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: GCO 17-0566|16-089 |
| | |
| | Start Date: March 1, 2018 |
| | |
| | Primary Completion Date: May 2023 |
| | |
| | Completion Date: May 2023 |
| | |
| | First Posted: July 19, 2017 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 2, 2020 |
| | |
| | Locations: Icahn School of Medicine at Mount Sinai, New York, New York, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03223103 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 27: | Study 27: |
| NCT Number: NCT03705351 | |
| Title: Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM | NCT Number: NCT03705351 |
| Acronym: | |
| Status: Recruiting | Title: Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Cancer of Brain|Glioblastoma Multiforme|Brain Tumor | Acronym: |
| Interventions: Device: Tumor Treating Fields|Drug: Temozolomide|Radiation: Radiation Therapy | |
| Outcome Measures: Rate of treatment-related adverse events associated with trimodal therapy|Severity of treatment-related adverse events associated with trimodal therapy|Progression-free survival at 6 months and 24 months|Overall Survival Rate | Status: Recruiting |
| Sponsor/Collaborators: Providence Health & Services|University of California, San Francisco|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma|Cancer of Brain|Glioblastoma Multiforme|Brain Tumor |
| Enrollment: 30 | |
| Funded Bys: Other|Industry | Interventions: Device: Tumor Treating Fields|Drug: Temozolomide|Radiation: Radiation Therapy |
| Study Type: Interventional | |
| Study Designs: Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Rate of treatment-related adverse events associated with trimodal therapy|Severity of treatment-related adverse events associated with trimodal therapy|Progression-free survival at 6 months and 24 months|Overall Survival Rate |
| Other IDs: UNITYGBM01 | |
| Start Date: December 2, 2019 | Sponsor/Collaborators: Providence Health & Services|University of California, San Francisco|NovoCure Ltd. |
| Primary Completion Date: November 1, 2023 | |
| Completion Date: November 1, 2025 | Gender: All |
| First Posted: October 15, 2018 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: May 28, 2020 | |
| Locations: University of California San Francisco, San Francisco, California, United States|Providence St. Vincent Medical Center, Portland, Oregon, United States | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03705351 | Enrollment: 30 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: UNITYGBM01 |
| | |
| | Start Date: December 2, 2019 |
| | |
| | Primary Completion Date: November 1, 2023 |
| | |
| | Completion Date: November 1, 2025 |
| | |
| | First Posted: October 15, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: May 28, 2020 |
| | |
| | Locations: University of California San Francisco, San Francisco, California, United States|Providence St. Vincent Medical Center, Portland, Oregon, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03705351 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 28: | Study 28: |
| NCT Number: NCT03353896 | |
| Title: NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma | NCT Number: NCT03353896 |
| Acronym: | |
| Status: Withdrawn | Title: NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma |
| Study Results: No Results Available | |
| Conditions: Anaplastic Oligodendroglioma|Oligoastrocytoma|Oligodendroglioma | Acronym: |
| Interventions: Device: Wear novoTTF-200A|Procedure: Quality-of-Life Assessment | |
| Outcome Measures: Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma | Status: Withdrawn |
| Sponsor/Collaborators: University of Southern California|National Cancer Institute (NCI)|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 19 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Anaplastic Oligodendroglioma|Oligoastrocytoma|Oligodendroglioma |
| Enrollment: 0 | |
| Funded Bys: Other|NIH|Industry | Interventions: Device: Wear novoTTF-200A|Procedure: Quality-of-Life Assessment |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma |
| Other IDs: 6B-15-1|NCI-2017-02074|EF-OLIGO-15|P30CA014089 | |
| Start Date: December 15, 2017 | Sponsor/Collaborators: University of Southern California|National Cancer Institute (NCI)|NovoCure Ltd. |
| Primary Completion Date: December 8, 2020 | |
| Completion Date: December 8, 2020 | Gender: All |
| First Posted: November 27, 2017 | |
| Results First Posted: | Age: 19 Years and older (Adult, Older Adult) |
| Last Update Posted: December 10, 2020 | |
| Locations: USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03353896 | Enrollment: 0 |
| | |
| | Funded Bys: Other|NIH|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 6B-15-1|NCI-2017-02074|EF-OLIGO-15|P30CA014089 |
| | |
| | Start Date: December 15, 2017 |
| | |
| | Primary Completion Date: December 8, 2020 |
| | |
| | Completion Date: December 8, 2020 |
| | |
| | First Posted: November 27, 2017 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: December 10, 2020 |
| | |
| | Locations: USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03353896 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 29: | Study 29: |
| NCT Number: NCT02893137 | |
| Title: Enhancing Optune Therapy With Targeted Craniectomy | NCT Number: NCT02893137 |
| Acronym: | |
| Status: Completed | Title: Enhancing Optune Therapy With Targeted Craniectomy |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Device: Optune|Procedure: Craniectomy | |
| Outcome Measures: Frequency of serious adverse events|Overall survival|Progression free survival|Progression free survival at six months|% 1-year survival|Objective response rate|Quality of life|Cumulative corticosteroid dosage|Karnofsky performance score | Status: Completed |
| Sponsor/Collaborators: Aarhus University Hospital|NovoCure Ltd.|University of Aarhus | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma |
| Enrollment: 15 | |
| Funded Bys: Other|Industry | Interventions: Device: Optune|Procedure: Craniectomy |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Frequency of serious adverse events|Overall survival|Progression free survival|Progression free survival at six months|% 1-year survival|Objective response rate|Quality of life|Cumulative corticosteroid dosage|Karnofsky performance score |
| Other IDs: 54762 | |
| Start Date: October 1, 2016 | Sponsor/Collaborators: Aarhus University Hospital|NovoCure Ltd.|University of Aarhus |
| Primary Completion Date: May 31, 2019 | |
| Completion Date: May 31, 2019 | Gender: All |
| First Posted: September 8, 2016 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: November 27, 2019 | |
| Locations: Aarhus University Hospital, Aarhus C, Aarhus, Denmark | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02893137 | Enrollment: 15 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 54762 |
| | |
| | Start Date: October 1, 2016 |
| | |
| | Primary Completion Date: May 31, 2019 |
| | |
| | Completion Date: May 31, 2019 |
| | |
| | First Posted: September 8, 2016 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: November 27, 2019 |
| | |
| | Locations: Aarhus University Hospital, Aarhus C, Aarhus, Denmark |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02893137 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 30: | Study 30: |
| NCT Number: NCT03477110 | |
| Title: Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma | NCT Number: NCT03477110 |
| Acronym: | |
| Status: Recruiting | Title: Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Drug: Temozolomide|Radiation: Radiation Therapy|Device: NovoTTF-200A Device|Procedure: Tumor Treating Fields Therapy | |
| Outcome Measures: NovoTTF-200A device discontinuation rate due to skin toxicity|Progression-free survival|Overall survival|Event-free survival | Status: Recruiting |
| Sponsor/Collaborators: Sidney Kimmel Cancer Center at Thomas Jefferson University|NovoCure Ltd.|Thomas Jefferson University | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Early Phase 1 | Conditions: Glioblastoma |
| Enrollment: 35 | |
| Funded Bys: Other|Industry | Interventions: Drug: Temozolomide|Radiation: Radiation Therapy|Device: NovoTTF-200A Device|Procedure: Tumor Treating Fields Therapy |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: NovoTTF-200A device discontinuation rate due to skin toxicity|Progression-free survival|Overall survival|Event-free survival |
| Other IDs: 17P.346 | |
| Start Date: May 4, 2018 | Sponsor/Collaborators: Sidney Kimmel Cancer Center at Thomas Jefferson University|NovoCure Ltd.|Thomas Jefferson University |
| Primary Completion Date: March 2021 | |
| Completion Date: September 2021 | Gender: All |
| First Posted: March 26, 2018 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: March 5, 2021 | |
| Locations: Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States | Phases: Early Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03477110 | Enrollment: 35 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 17P.346 |
| | |
| | Start Date: May 4, 2018 |
| | |
| | Primary Completion Date: March 2021 |
| | |
| | Completion Date: September 2021 |
| | |
| | First Posted: March 26, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: March 5, 2021 |
| | |
| | Locations: Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03477110 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 31: | Study 31: |
| NCT Number: NCT04397679 | |
| Title: Partial Brain Radiation Therapy, Temozolomide, Chloroquine, and Tumor Treating Fields Therapy for the Treatment of Newly Diagnosed Glioblastoma | NCT Number: NCT04397679 |
| Acronym: | |
| Status: Not yet recruiting | Title: Partial Brain Radiation Therapy, Temozolomide, Chloroquine, and Tumor Treating Fields Therapy for the Treatment of Newly Diagnosed Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Gliosarcoma | Acronym: |
| Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy|Radiation: Intensity-Modulated Radiation Therapy (IMRT)|Drug: Temozolomide|Drug: Chloroquine|Procedure: Tumor Treating Fields Therapy (TTF) | |
| Outcome Measures: Proportion of patients who develop a specific acute toxicity (dermatitis)|Incidence of adverse events | Status: Not yet recruiting |
| Sponsor/Collaborators: Barbara Ann Karmanos Cancer Institute|National Cancer Institute (NCI) | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma|Gliosarcoma |
| Enrollment: 10 | |
| Funded Bys: Other|NIH | Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy|Radiation: Intensity-Modulated Radiation Therapy (IMRT)|Drug: Temozolomide|Drug: Chloroquine|Procedure: Tumor Treating Fields Therapy (TTF) |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Proportion of patients who develop a specific acute toxicity (dermatitis)|Incidence of adverse events |
| Other IDs: 2018-148 | |
| Start Date: April 30, 2021 | Sponsor/Collaborators: Barbara Ann Karmanos Cancer Institute|National Cancer Institute (NCI) |
| Primary Completion Date: March 11, 2022 | |
| Completion Date: September 11, 2022 | Gender: All |
| First Posted: May 21, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: March 1, 2021 | |
| Locations: Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04397679 | Enrollment: 10 |
| | |
| | Funded Bys: Other|NIH |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 2018-148 |
| | |
| | Start Date: April 30, 2021 |
| | |
| | Primary Completion Date: March 11, 2022 |
| | |
| | Completion Date: September 11, 2022 |
| | |
| | First Posted: May 21, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: March 1, 2021 |
| | |
| | Locations: Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04397679 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 32: | Study 32: |
| NCT Number: NCT03687034 | |
| Title: A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma | NCT Number: NCT03687034 |
| Acronym: | |
| Status: Unknown status | Title: A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Drug: Temozolomide|Device: Optune | |
| Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Maximum tolerated dose|Levels of metabolites|Progression-free survival | Status: Unknown status |
| Sponsor/Collaborators: Leaf Vertical Inc. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years to 85 Years (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma |
| Enrollment: 21 | |
| Funded Bys: Industry | Interventions: Drug: Temozolomide|Device: Optune |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Maximum tolerated dose|Levels of metabolites|Progression-free survival |
| Other IDs: Olympian 2 | |
| Start Date: June 1, 2019 | Sponsor/Collaborators: Leaf Vertical Inc. |
| Primary Completion Date: September 30, 2019 | |
| Completion Date: December 31, 2020 | Gender: All |
| First Posted: September 27, 2018 | |
| Results First Posted: | Age: 18 Years to 85 Years (Adult, Older Adult) |
| Last Update Posted: February 26, 2019 | |
| Locations: | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03687034 | Enrollment: 21 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: Olympian 2 |
| | |
| | Start Date: June 1, 2019 |
| | |
| | Primary Completion Date: September 30, 2019 |
| | |
| | Completion Date: December 31, 2020 |
| | |
| | First Posted: September 27, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: February 26, 2019 |
| | |
| | Locations: |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03687034 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 33: | Study 33: |
| NCT Number: NCT04474353 | |
| Title: Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma | NCT Number: NCT04474353 |
| Acronym: | |
| Status: Not yet recruiting | Title: Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Newly Diagnosed Glioblastoma | Acronym: |
| Interventions: Device: Optune|Drug: Gadolinium|Drug: Temozolomide|Radiation: Stereotactic radiosurgery (SRS) | |
| Outcome Measures: Dose-limiting Toxicity (DLTs)|Acute dose limiting toxicity|Progression-free Survival (PFS) at 6 Months|Overall Survival (OS) | Status: Not yet recruiting |
| Sponsor/Collaborators: Stanford University|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma|Newly Diagnosed Glioblastoma |
| Enrollment: 12 | |
| Funded Bys: Other|Industry | Interventions: Device: Optune|Drug: Gadolinium|Drug: Temozolomide|Radiation: Stereotactic radiosurgery (SRS) |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Dose-limiting Toxicity (DLTs)|Acute dose limiting toxicity|Progression-free Survival (PFS) at 6 Months|Overall Survival (OS) |
| Other IDs: IRB-53582|BRN0043 | |
| Start Date: November 2020 | Sponsor/Collaborators: Stanford University|NovoCure Ltd. |
| Primary Completion Date: May 2023 | |
| Completion Date: November 2024 | Gender: All |
| First Posted: July 16, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: October 22, 2020 | |
| Locations: Stanford University, Stanford, California, United States | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04474353 | Enrollment: 12 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: IRB-53582|BRN0043 |
| | |
| | Start Date: November 2020 |
| | |
| | Primary Completion Date: May 2023 |
| | |
| | Completion Date: November 2024 |
| | |
| | First Posted: July 16, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: October 22, 2020 |
| | |
| | Locations: Stanford University, Stanford, California, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04474353 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 34: | Study 34: |
| NCT Number: NCT00749346 | |
| Title: NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer | NCT Number: NCT00749346 |
| Acronym: | |
| Status: Completed | Title: NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer |
| Study Results: No Results Available | |
| Conditions: Non-small Cell Lung Cancer|NSCLC | Acronym: |
| Interventions: Device: NovoTTF-100L | |
| Outcome Measures: Device related toxicity|Time to progression | Status: Completed |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1|Phase 2 | Conditions: Non-small Cell Lung Cancer|NSCLC |
| Enrollment: 42 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100L |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Device related toxicity|Time to progression |
| Other IDs: EF-15 | |
| Start Date: May 2008 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: July 2011 | |
| Completion Date: July 2011 | Gender: All |
| First Posted: September 9, 2008 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: September 27, 2011 | |
| Locations: CCRC, Basel, Switzerland|Kantonspital Graubunden, Chur, Switzerland|Kantonspital Fribourg, Fribourg, Switzerland|Kantonspital Winterthur, Winterthur, Switzerland | Phases: Phase 1|Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT00749346 | Enrollment: 42 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-15 |
| | |
| | Start Date: May 2008 |
| | |
| | Primary Completion Date: July 2011 |
| | |
| | Completion Date: July 2011 |
| | |
| | First Posted: September 9, 2008 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 27, 2011 |
| | |
| | Locations: CCRC, Basel, Switzerland|Kantonspital Graubunden, Chur, Switzerland|Kantonspital Fribourg, Fribourg, Switzerland|Kantonspital Winterthur, Winterthur, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT00749346 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 35: | Study 35: |
| NCT Number: NCT04469075 | |
| Title: Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields | NCT Number: NCT04469075 |
| Acronym: | |
| Status: Recruiting | Title: Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Skin Toxicity | Acronym: |
| Interventions: Drug: Clindamycin Phosphate|Drug: Triamcinolone Acetonide | |
| Outcome Measures: Number of patients without grade 2 or higher skin toxicity|skin-related quality of life | Status: Recruiting |
| Sponsor/Collaborators: Memorial Sloan Kettering Cancer Center | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Glioblastoma|Skin Toxicity |
| Enrollment: 58 | |
| Funded Bys: Other | Interventions: Drug: Clindamycin Phosphate|Drug: Triamcinolone Acetonide |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Number of patients without grade 2 or higher skin toxicity|skin-related quality of life |
| Other IDs: 19-342 | |
| Start Date: July 9, 2020 | Sponsor/Collaborators: Memorial Sloan Kettering Cancer Center |
| Primary Completion Date: July 2023 | |
| Completion Date: July 2023 | Gender: All |
| First Posted: July 13, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: April 1, 2021 | |
| Locations: Northwestern University, Evanston, Illinois, United States|Tufts Medical Center, Boston, Massachusetts, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Columbia University, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04469075 | Enrollment: 58 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 19-342 |
| | |
| | Start Date: July 9, 2020 |
| | |
| | Primary Completion Date: July 2023 |
| | |
| | Completion Date: July 2023 |
| | |
| | First Posted: July 13, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: April 1, 2021 |
| | |
| | Locations: Northwestern University, Evanston, Illinois, United States|Tufts Medical Center, Boston, Massachusetts, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Columbia University, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04469075 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 36: | Study 36: |
| NCT Number: NCT03980249 | |
| Title: Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells | NCT Number: NCT03980249 |
| Acronym: | |
| Status: Not yet recruiting | Title: Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Glioblastoma Multiforme | Acronym: |
| Interventions: Drug: Carvedilol | |
| Outcome Measures: Survival curve of overall survival|Survival curve of progression free survival|Quantify Circulating Tumor Cells (CTCs) | Status: Not yet recruiting |
| Sponsor/Collaborators: West Virginia University|NovoCure Ltd.|West Virginia Clinical and Translational Science Institute | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Early Phase 1 | Conditions: Glioblastoma|Glioblastoma Multiforme |
| Enrollment: 30 | |
| Funded Bys: Other|Industry | Interventions: Drug: Carvedilol |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Survival curve of overall survival|Survival curve of progression free survival|Quantify Circulating Tumor Cells (CTCs) |
| Other IDs: WVU020318 | |
| Start Date: September 2020 | Sponsor/Collaborators: West Virginia University|NovoCure Ltd.|West Virginia Clinical and Translational Science Institute |
| Primary Completion Date: December 2021 | |
| Completion Date: June 2022 | Gender: All |
| First Posted: June 10, 2019 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: November 4, 2019 | |
| Locations: WVU Cancer Institute - Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States | Phases: Early Phase 1 |
| Study Documents: "Informed Consent Form", https://ClinicalTrials.gov/ProvidedDocs/49/NCT03980249/ICF_000.pdf | |
| URL: https://ClinicalTrials.gov/show/NCT03980249 | Enrollment: 30 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: WVU020318 |
| | |
| | Start Date: September 2020 |
| | |
| | Primary Completion Date: December 2021 |
| | |
| | Completion Date: June 2022 |
| | |
| | First Posted: June 10, 2019 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: November 4, 2019 |
| | |
| | Locations: WVU Cancer Institute - Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States |
| | |
| | Study Documents: "Informed Consent Form", https://ClinicalTrials.gov/ProvidedDocs/49/NCT03980249/ICF_000.pdf |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03980249 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 37: | Study 37: |
| NCT Number: NCT03194971 | |
| Title: NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy | NCT Number: NCT03194971 |
| Acronym: | |
| Status: Recruiting | Title: NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy |
| Study Results: No Results Available | |
| Conditions: Glioblastoma | Acronym: |
| Interventions: Other: Tumor samples from patients treated with TTFields at initial diagnosis.|Device: Tumor samples from patients treated with TTFields at tumor recurrence. | |
| Outcome Measures: Number of mitotically active cells|Number of mitotically inactive cells|Mitotic Ratio | Status: Recruiting |
| Sponsor/Collaborators: Medical College of Wisconsin | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: | Conditions: Glioblastoma |
| Enrollment: 20 | |
| Funded Bys: Other | Interventions: Other: Tumor samples from patients treated with TTFields at initial diagnosis.|Device: Tumor samples from patients treated with TTFields at tumor recurrence. |
| Study Type: Observational | |
| Study Designs: Observational Model: Other|Time Perspective: Retrospective | Outcome Measures: Number of mitotically active cells|Number of mitotically inactive cells|Mitotic Ratio |
| Other IDs: PRO00017446 | |
| Start Date: June 1, 2017 | Sponsor/Collaborators: Medical College of Wisconsin |
| Primary Completion Date: May 31, 2021 | |
| Completion Date: May 31, 2022 | Gender: All |
| First Posted: June 21, 2017 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: December 16, 2020 | |
| Locations: Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States | Phases: |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03194971 | Enrollment: 20 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Observational |
| | |
| | Study Designs: Observational Model: Other|Time Perspective: Retrospective |
| | |
| | Other IDs: PRO00017446 |
| | |
| | Start Date: June 1, 2017 |
| | |
| | Primary Completion Date: May 31, 2021 |
| | |
| | Completion Date: May 31, 2022 |
| | |
| | First Posted: June 21, 2017 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: December 16, 2020 |
| | |
| | Locations: Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03194971 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 38: | Study 38: |
| NCT Number: NCT03607682 | |
| Title: Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer | NCT Number: NCT03607682 |
| Acronym: | |
| Status: Terminated | Title: Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer |
| Study Results: Has Results | |
| Conditions: Extensive Stage Small Cell Lung Carcinoma | Acronym: |
| Interventions: Procedure: Tumor Treating Fields (TTF) Therapy|Device: NovoTTF-200A Device|Other: Quality-of-Life Assessment | |
| Outcome Measures: Percentage of Patients Continuing Therapy Until Intracranial Tumor|Time to Intracranial Failure|Overall Survival|Rate of Intracranial Failure|Rate of Decline in Cognitive Function|Time to Neurocognitive Failure|Neurocognitive Failure-free Survival|Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30|Incidence of Adverse Events | Status: Terminated |
| Sponsor/Collaborators: Vanderbilt-Ingram Cancer Center|NovoCure Ltd. | |
| Gender: All | Study Results: Has Results |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Extensive Stage Small Cell Lung Carcinoma |
| Enrollment: 2 | |
| Funded Bys: Other|Industry | Interventions: Procedure: Tumor Treating Fields (TTF) Therapy|Device: NovoTTF-200A Device|Other: Quality-of-Life Assessment |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Percentage of Patients Continuing Therapy Until Intracranial Tumor|Time to Intracranial Failure|Overall Survival|Rate of Intracranial Failure|Rate of Decline in Cognitive Function|Time to Neurocognitive Failure|Neurocognitive Failure-free Survival|Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30|Incidence of Adverse Events |
| Other IDs: VICC THO 1747|NCI-2018-01428 | |
| Start Date: September 5, 2018 | Sponsor/Collaborators: Vanderbilt-Ingram Cancer Center|NovoCure Ltd. |
| Primary Completion Date: June 2, 2020 | |
| Completion Date: July 13, 2020 | Gender: All |
| First Posted: July 31, 2018 | |
| Results First Posted: August 4, 2020 | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: August 4, 2020 | |
| Locations: Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States | Phases: Not Applicable |
| Study Documents: "Study Protocol and Statistical Analysis Plan", https://ClinicalTrials.gov/ProvidedDocs/82/NCT03607682/Prot_SAP_000.pdf | |
| URL: https://ClinicalTrials.gov/show/NCT03607682 | Enrollment: 2 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: VICC THO 1747|NCI-2018-01428 |
| | |
| | Start Date: September 5, 2018 |
| | |
| | Primary Completion Date: June 2, 2020 |
| | |
| | Completion Date: July 13, 2020 |
| | |
| | First Posted: July 31, 2018 |
| | |
| | Results First Posted: August 4, 2020 |
| | |
| | Last Update Posted: August 4, 2020 |
| | |
| | Locations: Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States |
| | |
| | Study Documents: "Study Protocol and Statistical Analysis Plan", https://ClinicalTrials.gov/ProvidedDocs/82/NCT03607682/Prot_SAP_000.pdf |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03607682 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 39: | Study 39: |
| NCT Number: NCT04223999 | |
| Title: Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery) | NCT Number: NCT04223999 |
| Acronym: OptimalTTF-2 | |
| Status: Recruiting | Title: Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery) |
| Study Results: No Results Available | |
| Conditions: Recurrent Glioblastoma | Acronym: OptimalTTF-2 |
| Interventions: Procedure: Skullremodeling surgery|Other: Control | |
| Outcome Measures: OS12|Median OS|Median PFS|OS24|OS36|PFS6|ORR|Standardised and verified quality of life assessment questionnaires (QLQ-C30 and QLQ-BN20) for cancer and brain tumor patients.|Steroid dose|KPS|AE | Status: Recruiting |
| Sponsor/Collaborators: Anders Rosendal Korshøj|NovoCure GmbH|Odense University Hospital|University of Aarhus | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Recurrent Glioblastoma |
| Enrollment: 70 | |
| Funded Bys: Other|Industry | Interventions: Procedure: Skullremodeling surgery|Other: Control |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment | Outcome Measures: OS12|Median OS|Median PFS|OS24|OS36|PFS6|ORR|Standardised and verified quality of life assessment questionnaires (QLQ-C30 and QLQ-BN20) for cancer and brain tumor patients.|Steroid dose|KPS|AE |
| Other IDs: 150919V1|68928/1-10-72-214-19|658876/1-16-02-277-19|2019081231 | |
| Start Date: October 1, 2020 | Sponsor/Collaborators: Anders Rosendal Korshøj|NovoCure GmbH|Odense University Hospital|University of Aarhus |
| Primary Completion Date: March 1, 2023 | |
| Completion Date: March 1, 2024 | Gender: All |
| First Posted: January 13, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: November 5, 2020 | |
| Locations: Nikola Mikic, Aarhus, Denmark | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04223999 | Enrollment: 70 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment |
| | |
| | Other IDs: 150919V1|68928/1-10-72-214-19|658876/1-16-02-277-19|2019081231 |
| | |
| | Start Date: October 1, 2020 |
| | |
| | Primary Completion Date: March 1, 2023 |
| | |
| | Completion Date: March 1, 2024 |
| | |
| | First Posted: January 13, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: November 5, 2020 |
| | |
| | Locations: Nikola Mikic, Aarhus, Denmark |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04223999 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 40: | Study 40: |
| NCT Number: NCT00379470 | |
| Title: Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM) | NCT Number: NCT00379470 |
| Acronym: | |
| Status: Completed | Title: Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM) |
| Study Results: No Results Available | |
| Conditions: Recurrent Glioblastoma Multiforme | Acronym: |
| Interventions: Device: NovoTTF-100A | |
| Outcome Measures: Overall Survival|Progression free survival at 6 months (PFS6)|Median Time to Disease Progression (TTP)|% 1-year survival|Radiological response (Macdonald criteria)|Quality of life assessment (EORTC QLQ-C30)|Adverse events severity and frequency | Status: Completed |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 3 | Conditions: Recurrent Glioblastoma Multiforme |
| Enrollment: 236 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100A |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall Survival|Progression free survival at 6 months (PFS6)|Median Time to Disease Progression (TTP)|% 1-year survival|Radiological response (Macdonald criteria)|Quality of life assessment (EORTC QLQ-C30)|Adverse events severity and frequency |
| Other IDs: EF-11 | |
| Start Date: September 2006 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: November 2009 | |
| Completion Date: January 2011 | Gender: All |
| First Posted: September 21, 2006 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: May 1, 2012 | |
| Locations: Northwestern University, Chicago, Illinois, United States|University of Illinois in Chicago, Chicago, Illinois, United States|Evanston Northwestern Healthcare, Evanston, Illinois, United States|Boston University Medical Center, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Lahey Clinic Medical Center, Burlington, Massachusetts, United States|NJ Neuroscience Institute - JFK Medical Center, Edison, New Jersey, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Weill Cornell Medical College, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|University Hospitals of Cleveland, Cleveland, Ohio, United States|Cleveland Clinic, Cleveland, Ohio, United States|University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States|University of Virginia, Charlottesville, Virginia, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States|University Hospital Graz, Graz, Austria|FN Brno - Masaryk University, Brno, Czech Republic|Na Homolce Hospital, Prague, Czech Republic|Hospital of Neurology Lyon - University Claude Bernard Lyon 1, Lyon, France|Group Hospitals Pitie-Salpetriere, Paris, France|University Hospital Augsburg, Augsburg, Germany|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|University Hospital of Schleswig-Holstein, Kiel, Germany|Tel Aviv Sourasky Medical Center, Tel Aviv, Israel|Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland | Phases: Phase 3 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT00379470 | Enrollment: 236 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-11 |
| | |
| | Start Date: September 2006 |
| | |
| | Primary Completion Date: November 2009 |
| | |
| | Completion Date: January 2011 |
| | |
| | First Posted: September 21, 2006 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: May 1, 2012 |
| | |
| | Locations: Northwestern University, Chicago, Illinois, United States|University of Illinois in Chicago, Chicago, Illinois, United States|Evanston Northwestern Healthcare, Evanston, Illinois, United States|Boston University Medical Center, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Lahey Clinic Medical Center, Burlington, Massachusetts, United States|NJ Neuroscience Institute - JFK Medical Center, Edison, New Jersey, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Weill Cornell Medical College, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|University Hospitals of Cleveland, Cleveland, Ohio, United States|Cleveland Clinic, Cleveland, Ohio, United States|University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States|University of Virginia, Charlottesville, Virginia, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States|University Hospital Graz, Graz, Austria|FN Brno - Masaryk University, Brno, Czech Republic|Na Homolce Hospital, Prague, Czech Republic|Hospital of Neurology Lyon - University Claude Bernard Lyon 1, Lyon, France|Group Hospitals Pitie-Salpetriere, Paris, France|University Hospital Augsburg, Augsburg, Germany|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|University Hospital of Schleswig-Holstein, Kiel, Germany|Tel Aviv Sourasky Medical Center, Tel Aviv, Israel|Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT00379470 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 41: | Study 41: |
| NCT Number: NCT00916409 | |
| Title: Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM) | NCT Number: NCT00916409 |
| Acronym: | |
| Status: Completed | Title: Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM) |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme | Acronym: |
| Interventions: Device: NovoTTF-100A device|Drug: Temozolomide | |
| Outcome Measures: Progression Free Survival (PFS) time|Overall survival (OS) | Status: Completed |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 3 | Conditions: Glioblastoma Multiforme |
| Enrollment: 700 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100A device|Drug: Temozolomide |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Progression Free Survival (PFS) time|Overall survival (OS) |
| Other IDs: EF-14 | |
| Start Date: June 2009 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: December 2016 | |
| Completion Date: March 2017 | Gender: All |
| First Posted: June 9, 2009 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: April 10, 2017 | |
| Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States|Barrow Neurology Clinics, Phoenix, Arizona, United States|City of Hope, Duarte, California, United States|University of California San Diego Moores Cancer Center (UCSD), La Jolla, California, United States|University of Southern California (USC), Los Angeles, California, United States|University of Colorado Denver, Aurora, Colorado, United States|UF Health Cancer Center at Orlando Health, Orlando, Florida, United States|H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States|Emory University, Winship Cancer Institute, Atlanta, Georgia, United States|University of Illinois at Chicago (UIC), Chicago, Illinois, United States|University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States|Norton Cancer Institute, Louisville, Kentucky, United States|Maine Medical Center, Scarborough, Maine, United States|The Johns Hopkins Hospital, Baltimore, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Lahey Clinic Medical Center, Burlington, Massachusetts, United States|Henry Ford Health System, Detroit, Michigan, United States|Washington University School of Medicine, Division of Oncology, St. Louis, Missouri, United States|New Jersey Neuroscience Center - JFK Medical Center, Edison, New Jersey, United States|John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States|Weill Cornell Medical College, New York, New York, United States|Mount Sinai Medical Center, Department of Neurosurgery, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|University of North Carolina, Chapel Hill, North Carolina, United States|Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States|The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States|Geisinger Health System, Danville, Pennsylvania, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|Pennsylvania Hospital, Philadelphia, Pennsylvania, United States|University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States|UT Southwestern Medical Center, Dallas, Texas, United States|Baylor, Dallas, Texas, United States|Methodist Hospital, Houston, Texas, United States|Methodist Neurological Institute, Houston, Texas, United States|The University of Texas Health Science Center at Houston (UTHSC), Houston, Texas, United States|Scott and White Healthcare, Temple, Texas, United States|Memorial Hermann The Woodlands, The Woodlands, Texas, United States|University of Virginia Health System, Charlottesville, Virginia, United States|Swedish Neuroscience Institute, Seattle, Washington, United States|University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States|University Hospital Graz, Graz, Austria|Medical University of Vienna, Vienna, Austria|SMZ-Süd/Kaiser-Franz-Josef-Spital, Vienna, Austria|Tom Baker Cancer Center, Calgary, Alberta, Canada|CancerCare Manitoba, Winnipeg, Manitoba, Canada|Juravinski Cancer Centre, Hamilton,, Ontario, Canada|The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada|Notre-Dame Hospital (CHUM), Montreal, Quebec, Canada|Montreal Neurological Institute, Montreal, Quebec, Canada|McGill - Gerald Bronfman Centre for Clinical Research in Oncology -, Montreal, Quebec, Canada|(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie, Sherbrooke, Quebec, Canada|Na Homolce Hospital, Prague, Czech Republic|CHU Amiens Sud-Salouel, Amiens, France|CHU Angers, Angers, France|Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux, Bordeaux, France|Hospital of Neurology Pierre Wertheimer, Lyon, France|Group Hospitals Pitie-Salpetriere, Paris, France|Centre Hospitalo-Universitaire de Toulouse Purpan, Toulouse, France|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|Medical University Heidelberg, Heidelberg, Germany|University Hospital of Schleswig-Holstein, Kiel, Germany|Tel Aviv Sourasky Medical Center, Tel Aviv, Israel|Az. Ospedaliero-Universitaria - Ospedali Riuniti, Ancona, Italy|Ospedale Lecco, Lecco, Italy|C. Besta Neurological Institute, Milan, Italy|Foundation Hospital Greater Policlinico, Milan, Italy|Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena, Rome, Italy|Asan Medical Center, Asan, Korea, Republic of|Yeungnam University Hospital, Daegu, Korea, Republic of|Chungnam National University Hospital (CNUH), Daejeon, Korea, Republic of|Samsung Medical Center (SMC), Seoul, Korea, Republic of|Seoul National University Bundang Hospital (SNUBH), Seoul, Korea, Republic of|Seoul National University Hospital (SNUH), Seoul, Korea, Republic of|The Catholic University of Korea, Seoul St. Mary's Hospital (CMC Seoul), Seoul, Korea, Republic of|Yonsei University Severance Hospital (YUHS), Seoul, Korea, Republic of|Ajou University Hospital (AUH), Suwon, Korea, Republic of|Hospital Universitari Germans Trias i Pujol, Badalona, Spain|Hospital Clinic i Provincial de Barcelona, Barcelona, Spain|Hospital del Mar, Barcelona, Spain|Hospital Universitari de Bellvitge-ICO Duran i Reynals, Barcelona, Spain|Fundacion Jimenes Diaz, Madrid, Spain|Hospital 12 de Octubre, Servicio de Oncología Médica, Madrid, Spain|Hospital Clinico San Carlos, Madrid, Spain|Hospital Universitario Ramon y Cajal, Madrid, Spain|Clínica Universidad de Navarra, Pamplona, Spain|Karolinska Institute, Stockholm, Sweden|Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland|UniversitätsSpital Zürich, Zurich, Switzerland | Phases: Phase 3 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT00916409 | Enrollment: 700 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-14 |
| | |
| | Start Date: June 2009 |
| | |
| | Primary Completion Date: December 2016 |
| | |
| | Completion Date: March 2017 |
| | |
| | First Posted: June 9, 2009 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: April 10, 2017 |
| | |
| | Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States|Barrow Neurology Clinics, Phoenix, Arizona, United States|City of Hope, Duarte, California, United States|University of California San Diego Moores Cancer Center (UCSD), La Jolla, California, United States|University of Southern California (USC), Los Angeles, California, United States|University of Colorado Denver, Aurora, Colorado, United States|UF Health Cancer Center at Orlando Health, Orlando, Florida, United States|H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States|Emory University, Winship Cancer Institute, Atlanta, Georgia, United States|University of Illinois at Chicago (UIC), Chicago, Illinois, United States|University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States|Norton Cancer Institute, Louisville, Kentucky, United States|Maine Medical Center, Scarborough, Maine, United States|The Johns Hopkins Hospital, Baltimore, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Lahey Clinic Medical Center, Burlington, Massachusetts, United States|Henry Ford Health System, Detroit, Michigan, United States|Washington University School of Medicine, Division of Oncology, St. Louis, Missouri, United States|New Jersey Neuroscience Center - JFK Medical Center, Edison, New Jersey, United States|John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States|Weill Cornell Medical College, New York, New York, United States|Mount Sinai Medical Center, Department of Neurosurgery, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|University of North Carolina, Chapel Hill, North Carolina, United States|Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States|The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States|Geisinger Health System, Danville, Pennsylvania, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|Pennsylvania Hospital, Philadelphia, Pennsylvania, United States|University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States|UT Southwestern Medical Center, Dallas, Texas, United States|Baylor, Dallas, Texas, United States|Methodist Hospital, Houston, Texas, United States|Methodist Neurological Institute, Houston, Texas, United States|The University of Texas Health Science Center at Houston (UTHSC), Houston, Texas, United States|Scott and White Healthcare, Temple, Texas, United States|Memorial Hermann The Woodlands, The Woodlands, Texas, United States|University of Virginia Health System, Charlottesville, Virginia, United States|Swedish Neuroscience Institute, Seattle, Washington, United States|University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States|University Hospital Graz, Graz, Austria|Medical University of Vienna, Vienna, Austria|SMZ-Süd/Kaiser-Franz-Josef-Spital, Vienna, Austria|Tom Baker Cancer Center, Calgary, Alberta, Canada|CancerCare Manitoba, Winnipeg, Manitoba, Canada|Juravinski Cancer Centre, Hamilton,, Ontario, Canada|The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada|Notre-Dame Hospital (CHUM), Montreal, Quebec, Canada|Montreal Neurological Institute, Montreal, Quebec, Canada|McGill - Gerald Bronfman Centre for Clinical Research in Oncology -, Montreal, Quebec, Canada|(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie, Sherbrooke, Quebec, Canada|Na Homolce Hospital, Prague, Czech Republic|CHU Amiens Sud-Salouel, Amiens, France|CHU Angers, Angers, France|Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux, Bordeaux, France|Hospital of Neurology Pierre Wertheimer, Lyon, France|Group Hospitals Pitie-Salpetriere, Paris, France|Centre Hospitalo-Universitaire de Toulouse Purpan, Toulouse, France|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|Medical University Heidelberg, Heidelberg, Germany|University Hospital of Schleswig-Holstein, Kiel, Germany|Tel Aviv Sourasky Medical Center, Tel Aviv, Israel|Az. Ospedaliero-Universitaria - Ospedali Riuniti, Ancona, Italy|Ospedale Lecco, Lecco, Italy|C. Besta Neurological Institute, Milan, Italy|Foundation Hospital Greater Policlinico, Milan, Italy|Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena, Rome, Italy|Asan Medical Center, Asan, Korea, Republic of|Yeungnam University Hospital, Daegu, Korea, Republic of|Chungnam National University Hospital (CNUH), Daejeon, Korea, Republic of|Samsung Medical Center (SMC), Seoul, Korea, Republic of|Seoul National University Bundang Hospital (SNUBH), Seoul, Korea, Republic of|Seoul National University Hospital (SNUH), Seoul, Korea, Republic of|The Catholic University of Korea, Seoul St. Mary's Hospital (CMC Seoul), Seoul, Korea, Republic of|Yonsei University Severance Hospital (YUHS), Seoul, Korea, Republic of|Ajou University Hospital (AUH), Suwon, Korea, Republic of|Hospital Universitari Germans Trias i Pujol, Badalona, Spain|Hospital Clinic i Provincial de Barcelona, Barcelona, Spain|Hospital del Mar, Barcelona, Spain|Hospital Universitari de Bellvitge-ICO Duran i Reynals, Barcelona, Spain|Fundacion Jimenes Diaz, Madrid, Spain|Hospital 12 de Octubre, Servicio de Oncología Médica, Madrid, Spain|Hospital Clinico San Carlos, Madrid, Spain|Hospital Universitario Ramon y Cajal, Madrid, Spain|Clínica Universidad de Navarra, Pamplona, Spain|Karolinska Institute, Stockholm, Sweden|Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland|UniversitätsSpital Zürich, Zurich, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT00916409 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 42: | Study 42: |
| NCT Number: NCT01894061 | |
| Title: NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma | NCT Number: NCT01894061 |
| Acronym: | |
| Status: Completed | Title: NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma |
| Study Results: No Results Available | |
| Conditions: Adult Giant Cell Glioblastoma|Adult Glioblastoma|Adult Gliosarcoma|Recurrent Adult Brain Tumor | Acronym: |
| Interventions: Biological: Bevacizumab|Device: NovoTTF-l00A|Other: Quality of Life Assessment | |
| Outcome Measures: Progression Free Survival (PFS)|Objective response rate based on RANO Criteria|Number of patients that experience toxicities with this combination of therapies|Median overall survival|To assess time-to-progression|Neurocognitive function (NCF)|Quality of Life (QOL) | Status: Completed |
| Sponsor/Collaborators: Case Comprehensive Cancer Center|NovoCure Ltd.|National Cancer Institute (NCI) | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Adult Giant Cell Glioblastoma|Adult Glioblastoma|Adult Gliosarcoma|Recurrent Adult Brain Tumor |
| Enrollment: 25 | |
| Funded Bys: Other|Industry|NIH | Interventions: Biological: Bevacizumab|Device: NovoTTF-l00A|Other: Quality of Life Assessment |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Progression Free Survival (PFS)|Objective response rate based on RANO Criteria|Number of patients that experience toxicities with this combination of therapies|Median overall survival|To assess time-to-progression|Neurocognitive function (NCF)|Quality of Life (QOL) |
| Other IDs: CASE3313 | |
| Start Date: June 12, 2013 | Sponsor/Collaborators: Case Comprehensive Cancer Center|NovoCure Ltd.|National Cancer Institute (NCI) |
| Primary Completion Date: July 28, 2019 | |
| Completion Date: July 28, 2019 | Gender: All |
| First Posted: July 9, 2013 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: July 24, 2020 | |
| Locations: University of Cincinnati, Cincinnati, Ohio, United States|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT01894061 | Enrollment: 25 |
| | |
| | Funded Bys: Other|Industry|NIH |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: CASE3313 |
| | |
| | Start Date: June 12, 2013 |
| | |
| | Primary Completion Date: July 28, 2019 |
| | |
| | Completion Date: July 28, 2019 |
| | |
| | First Posted: July 9, 2013 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: July 24, 2020 |
| | |
| | Locations: University of Cincinnati, Cincinnati, Ohio, United States|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT01894061 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 43: | Study 43: |
| NCT Number: NCT01925573 | |
| Title: Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344) | NCT Number: NCT01925573 |
| Acronym: | |
| Status: Terminated | Title: Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344) |
| Study Results: No Results Available | |
| Conditions: RECURRENT GLIOBLASTOMA|Brain Tumor | Acronym: |
| Interventions: Device: Optune(NOVOTTF-100A) | |
| Outcome Measures: Number of Adverse Events with a grade 3 or high toxicity (Primary Measure) | Status: Terminated |
| Sponsor/Collaborators: University of Maryland, Baltimore|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: RECURRENT GLIOBLASTOMA|Brain Tumor |
| Enrollment: 7 | |
| Funded Bys: Other|Industry | Interventions: Device: Optune(NOVOTTF-100A) |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Number of Adverse Events with a grade 3 or high toxicity (Primary Measure) |
| Other IDs: HP-00056719 | |
| Start Date: May 2014 | Sponsor/Collaborators: University of Maryland, Baltimore|NovoCure Ltd. |
| Primary Completion Date: August 2019 | |
| Completion Date: August 2019 | Gender: All |
| First Posted: August 19, 2013 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: November 4, 2020 | |
| Locations: Ummc Msgcc, Baltimore, Maryland, United States | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT01925573 | Enrollment: 7 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: HP-00056719 |
| | |
| | Start Date: May 2014 |
| | |
| | Primary Completion Date: August 2019 |
| | |
| | Completion Date: August 2019 |
| | |
| | First Posted: August 19, 2013 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: November 4, 2020 |
| | |
| | Locations: Ummc Msgcc, Baltimore, Maryland, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT01925573 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 44: | Study 44: |
| NCT Number: NCT03861598 | |
| Title: Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells | NCT Number: NCT03861598 |
| Acronym: | |
| Status: Recruiting | Title: Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme|Glioblastoma | Acronym: |
| Interventions: Drug: Carvedilol | |
| Outcome Measures: Identify the correlation between our new RT-qPCR assay for circulating tumor cells and the change in responses in patients on treatment to MRI results.|Evaluate response with the addition of carvedilol to standard chemotherapy in the second line treatment in glioblastoma multiforme|Evaluate incidents of adverse events during the time subjects are taking carvedilol with chemotherapy | Status: Recruiting |
| Sponsor/Collaborators: West Virginia University|West Virginia Clinical and Translational Science Institute | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Early Phase 1 | Conditions: Glioblastoma Multiforme|Glioblastoma |
| Enrollment: 6 | |
| Funded Bys: Other | Interventions: Drug: Carvedilol |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Identify the correlation between our new RT-qPCR assay for circulating tumor cells and the change in responses in patients on treatment to MRI results.|Evaluate response with the addition of carvedilol to standard chemotherapy in the second line treatment in glioblastoma multiforme|Evaluate incidents of adverse events during the time subjects are taking carvedilol with chemotherapy |
| Other IDs: WVU010318 | |
| Start Date: July 19, 2019 | Sponsor/Collaborators: West Virginia University|West Virginia Clinical and Translational Science Institute |
| Primary Completion Date: July 1, 2021 | |
| Completion Date: July 1, 2021 | Gender: All |
| First Posted: March 4, 2019 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: August 4, 2020 | |
| Locations: WVU Cancer Institute - Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States | Phases: Early Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03861598 | Enrollment: 6 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: WVU010318 |
| | |
| | Start Date: July 19, 2019 |
| | |
| | Primary Completion Date: July 1, 2021 |
| | |
| | Completion Date: July 1, 2021 |
| | |
| | First Posted: March 4, 2019 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: August 4, 2020 |
| | |
| | Locations: WVU Cancer Institute - Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03861598 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 45: | Study 45: |
| NCT Number: NCT04471844 | |
| Title: Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM | NCT Number: NCT04471844 |
| Acronym: EF-32 | |
| Status: Recruiting | Title: Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme | Acronym: EF-32 |
| Interventions: Device: Optune® | |
| Outcome Measures: Overall Survival (OS)|Progression Free Survival (PFS)|1- and 2-year survival rates|Overall Radiological response (ORR)|Next progression-free survival (PFS2)|Progression-free survival at 6 (PFS6) and 12 months (PFS12)|Severity and frequency of adverse events|Pathological changes in resected GBM tumors following study treatments|Quality of Life EORTC Questionnaire|Dependence of overall survival on TTFields dose at the tumor|The NANO scale | Status: Recruiting |
| Sponsor/Collaborators: NovoCure GmbH|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Glioblastoma Multiforme |
| Enrollment: 950 | |
| Funded Bys: Industry | Interventions: Device: Optune® |
| Study Type: Interventional | |
| Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall Survival (OS)|Progression Free Survival (PFS)|1- and 2-year survival rates|Overall Radiological response (ORR)|Next progression-free survival (PFS2)|Progression-free survival at 6 (PFS6) and 12 months (PFS12)|Severity and frequency of adverse events|Pathological changes in resected GBM tumors following study treatments|Quality of Life EORTC Questionnaire|Dependence of overall survival on TTFields dose at the tumor|The NANO scale |
| Other IDs: TRIDENT EF-32 | |
| Start Date: December 8, 2020 | Sponsor/Collaborators: NovoCure GmbH|NovoCure Ltd. |
| Primary Completion Date: August 2024 | |
| Completion Date: August 2026 | Gender: All |
| First Posted: July 15, 2020 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: February 21, 2021 | |
| Locations: Grandview Cancer Center, Birmingham, Alabama, United States|St. Joseph's Hospital and Medical Center - Barrow Neurological Institute, Phoenix, Arizona, United States|Mayo Clinic- Arizona, Phoenix, Arizona, United States|University of Arizona Cancer Center, Tucson, Arizona, United States|Highland Oncology Group, Fayetteville, Arkansas, United States|City of Hope National Medical Center, Duarte, California, United States|TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center, Fullerton, California, United States|University of California at San Diego - Moores Cancer Center, La Jolla, California, United States|Memorial Care Cancer Institute - Long Beach Memorial Medical Center, Long Beach, California, United States|Norris Comprehensive Cancer Center at USC, Los Angeles, California, United States|Cedars - Sinai Medical Center, Los Angeles, California, United States|St. Joseph's Hospital, Orange, California, United States|University of California - Irvine/UCI Medical Center, Orange, California, United States|Kaiser Permanente Redwood City Medical Center, Redwood City, California, United States|Kaiser Permanente Medical Center Sacramento, Sacramento, California, United States|Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology, San Diego, California, United States|John Wayne Cancer Institute at St. John's Health Center, Santa Monica, California, United States|Stanford Cancer Institute, Stanford, California, United States|University of Colorado Cancer Center Anschutz, Aurora, Colorado, United States|HCA Research Institute - Blue Sky Neurology - Denver, Englewood, Colorado, United States|Yale University Smilow Cancer Hospital, New Haven, Connecticut, United States|Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center, New London, Connecticut, United States|Boca Raton Regional Hospital, Boca Raton, Florida, United States|Baptist Health - Jacksonville, Jacksonville, Florida, United States|Advent Health, Orlando, Florida, United States|Orlando Health UF Health Cancer Center, Orlando, Florida, United States|H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States|Piedmont Healthcare Brain Tumor Center, Atlanta, Georgia, United States|The Emory Clinic - Emory Healthcare - Winship Cancer Institute, Atlanta, Georgia, United States|Rush University Medical Center, Chicago, Illinois, United States|Northwestern University, Evanston, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates, Fort Wayne, Indiana, United States|The University of Kansas Cancer Center, Overland Park, Kansas, United States|University of Louisville - James Graham Brown Cancer Center, Louisville, Kentucky, United States|Norton Cancer Institute, Louisville, Kentucky, United States|NeuroMedical Center - DelRicht Research, Baton Rouge, Louisiana, United States|LSU Health Sciences, New Orleans, Louisiana, United States|Ochsner Health System, New Orleans, Louisiana, United States|Maine Medical Partners Neurology - Neurosurgery & Spine Associates, Scarborough, Maine, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States|Abbott Northwestern Hospital - Givens Brain Tumor Center, Minneapolis, Minnesota, United States|University of Minnesota Health Clinics and Surgery Center, Minneapolis, Minnesota, United States|Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine, Kansas City, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States|JFK Medical Center - JFK Brain Tumor Center, Edison, New Jersey, United States|Hackensack University Medical Center - John Theurer Cancer Center, Hackensack, New Jersey, United States|Northwell Health System Brain Tumor Center, Lake Success, New York, United States|NYU Langone - Laura & Issac Perimutter Cancer Center, New York, New York, United States|Mount Sinai - Icahn School of Medicine, New York, New York, United States|New York Presbyterian - Columbia University, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States|Vidant Medical Center, Greenville, North Carolina, United States|Forsyth Medical Center-Novant Health, Winston-Salem, North Carolina, United States|Comprehensive Cancer Center of Wake Forest University - Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States|University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States|Case Western - University Hospitals Case Medical Center, Cleveland, Ohio, United States|The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital, Columbus, Ohio, United States|Providence St Vincent Medical Center, Portland, Oregon, United States|Oregon Health & Science University, Portland, Oregon, United States|Geisinger Health System, Danville, Pennsylvania, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States|University of Pittsburgh Medical Center Health System - Center for Neuro-Oncology - Hillman Cancer Institute, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital, Providence, Rhode Island, United States|MUSC Radiation Oncology Brain & Spine Tumor Program, Charleston, South Carolina, United States|West Cancer Center - Germantown, Germantown, Tennessee, United States|SCRI - Tennessee Oncology, Nashville, Tennessee, United States|Texas Oncology Midtown - Austin Brain Tumor Center, Austin, Texas, United States|Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center, Dallas, Texas, United States|John Peter Smith Health Network - JPS Cancer Center, Fort Worth, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences, Houston, Texas, United States|San Antonio Cancer Institute, San Antonio, Texas, United States|Baylor Scott & White Medical Center, Temple, Texas, United States|Huntsman Cancer Institute, Salt Lake City, Utah, United States|The University of Vermont Medical Center - University of Vermont Cancer Center, Burlington, Vermont, United States|Massey Cancer Center - VCU Medical Center, Richmond, Virginia, United States|UW Medical Center - Alvord Brain Tumor Center, Seattle, Washington, United States|West Virginia University Cancer Institute, Morgantown, West Virginia, United States|Innsbruck State Hospital, Innsbruck, Austria|Kepler University Hospital, Linz, Austria|University Hospital Salzburg, Salzburg, Austria|Hospital Erasme, Brussels, Belgium|CHU de Liege - du Sart Tilman, Liège, Belgium|BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada|The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada|Princess Margaret Cancer Centre, Toronto, Ontario, Canada|CHUM Centre de Recherche, Montréal, Quebec, Canada|Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita, Sherbrooke, Quebec, Canada|Masaryk Memorial Cancer Institute, Brno, Czechia|University Hospital Plzeñ, Pilsen, Czechia|Na Homolce Hospital, Prague, Czechia|Hospital CHU Nice, Nice, France|Hopital de la Pitie Salpetriere, Paris, France|Institut de Cancerologie de l'Ouest, Saint Herblain, France|Institut Universitaire du Cancer de Toulouse, Toulouse, France|Institut Gusatve Roussy, Villejuif, France|University Hospital Berlin, Berlin, Germany|University Hospital Essen, Essen, Germany|University Hospital Tübingen, Tübingen, Germany|Rambam Medical Center, Haifa, Israel|Rabin Medical Center, Petah Tikva, Israel|Sheba Medical Center, Ramat Gan, Israel|Tel Aviv Sourasky Medical Center, Tel Aviv, Israel|CHUV - Centre Hospitalier Universitaire Vaudois, Department of Clinical Neurosciences and Oncology, Lausanne, Switzerland|University Hospital Zurich, Zürich, Switzerland | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT04471844 | Enrollment: 950 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: TRIDENT EF-32 |
| | |
| | Start Date: December 8, 2020 |
| | |
| | Primary Completion Date: August 2024 |
| | |
| | Completion Date: August 2026 |
| | |
| | First Posted: July 15, 2020 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: February 21, 2021 |
| | |
| | Locations: Grandview Cancer Center, Birmingham, Alabama, United States|St. Joseph's Hospital and Medical Center - Barrow Neurological Institute, Phoenix, Arizona, United States|Mayo Clinic- Arizona, Phoenix, Arizona, United States|University of Arizona Cancer Center, Tucson, Arizona, United States|Highland Oncology Group, Fayetteville, Arkansas, United States|City of Hope National Medical Center, Duarte, California, United States|TRIO - St. Jude Heritage Healthcare/St. Jude Medical Center, Fullerton, California, United States|University of California at San Diego - Moores Cancer Center, La Jolla, California, United States|Memorial Care Cancer Institute - Long Beach Memorial Medical Center, Long Beach, California, United States|Norris Comprehensive Cancer Center at USC, Los Angeles, California, United States|Cedars - Sinai Medical Center, Los Angeles, California, United States|St. Joseph's Hospital, Orange, California, United States|University of California - Irvine/UCI Medical Center, Orange, California, United States|Kaiser Permanente Redwood City Medical Center, Redwood City, California, United States|Kaiser Permanente Medical Center Sacramento, Sacramento, California, United States|Sharp Memorial Hospital - X-Ray Medical Group Radiation Oncology, San Diego, California, United States|John Wayne Cancer Institute at St. John's Health Center, Santa Monica, California, United States|Stanford Cancer Institute, Stanford, California, United States|University of Colorado Cancer Center Anschutz, Aurora, Colorado, United States|HCA Research Institute - Blue Sky Neurology - Denver, Englewood, Colorado, United States|Yale University Smilow Cancer Hospital, New Haven, Connecticut, United States|Hartford Healthcare Medical Group - Hartford Hospital The Gray Cancer Center, New London, Connecticut, United States|Boca Raton Regional Hospital, Boca Raton, Florida, United States|Baptist Health - Jacksonville, Jacksonville, Florida, United States|Advent Health, Orlando, Florida, United States|Orlando Health UF Health Cancer Center, Orlando, Florida, United States|H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States|Piedmont Healthcare Brain Tumor Center, Atlanta, Georgia, United States|The Emory Clinic - Emory Healthcare - Winship Cancer Institute, Atlanta, Georgia, United States|Rush University Medical Center, Chicago, Illinois, United States|Northwestern University, Evanston, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|Parkview Cancer Institute - Fort Wayne Radiation Oncology Associates, Fort Wayne, Indiana, United States|The University of Kansas Cancer Center, Overland Park, Kansas, United States|University of Louisville - James Graham Brown Cancer Center, Louisville, Kentucky, United States|Norton Cancer Institute, Louisville, Kentucky, United States|NeuroMedical Center - DelRicht Research, Baton Rouge, Louisiana, United States|LSU Health Sciences, New Orleans, Louisiana, United States|Ochsner Health System, New Orleans, Louisiana, United States|Maine Medical Partners Neurology - Neurosurgery & Spine Associates, Scarborough, Maine, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States|Abbott Northwestern Hospital - Givens Brain Tumor Center, Minneapolis, Minnesota, United States|University of Minnesota Health Clinics and Surgery Center, Minneapolis, Minnesota, United States|Health Midwest Ventures Group, Inc - Sarah Cannon HCA Midwest Brain and Spine, Kansas City, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States|JFK Medical Center - JFK Brain Tumor Center, Edison, New Jersey, United States|Hackensack University Medical Center - John Theurer Cancer Center, Hackensack, New Jersey, United States|Northwell Health System Brain Tumor Center, Lake Success, New York, United States|NYU Langone - Laura & Issac Perimutter Cancer Center, New York, New York, United States|Mount Sinai - Icahn School of Medicine, New York, New York, United States|New York Presbyterian - Columbia University, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|University of North Carolina Brain Tumor Program - UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States|Vidant Medical Center, Greenville, North Carolina, United States|Forsyth Medical Center-Novant Health, Winston-Salem, North Carolina, United States|Comprehensive Cancer Center of Wake Forest University - Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States|University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States|Case Western - University Hospitals Case Medical Center, Cleveland, Ohio, United States|The James Cancer Hospital and Solove Research Institute - Arthur G James Cancer Hospital, Columbus, Ohio, United States|Providence St Vincent Medical Center, Portland, Oregon, United States|Oregon Health & Science University, Portland, Oregon, United States|Geisinger Health System, Danville, Pennsylvania, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States|University of Pittsburgh Medical Center Health System - Center for Neuro-Oncology - Hillman Cancer Institute, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital, Providence, Rhode Island, United States|MUSC Radiation Oncology Brain & Spine Tumor Program, Charleston, South Carolina, United States|West Cancer Center - Germantown, Germantown, Tennessee, United States|SCRI - Tennessee Oncology, Nashville, Tennessee, United States|Texas Oncology Midtown - Austin Brain Tumor Center, Austin, Texas, United States|Baylor Charles A. Sammons Cancer Center - Baylor University Medical Center, Dallas, Texas, United States|John Peter Smith Health Network - JPS Cancer Center, Fort Worth, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|UT Health Mischer Neuroscience - Memorial Herman - UT Neurosciences, Houston, Texas, United States|San Antonio Cancer Institute, San Antonio, Texas, United States|Baylor Scott & White Medical Center, Temple, Texas, United States|Huntsman Cancer Institute, Salt Lake City, Utah, United States|The University of Vermont Medical Center - University of Vermont Cancer Center, Burlington, Vermont, United States|Massey Cancer Center - VCU Medical Center, Richmond, Virginia, United States|UW Medical Center - Alvord Brain Tumor Center, Seattle, Washington, United States|West Virginia University Cancer Institute, Morgantown, West Virginia, United States|Innsbruck State Hospital, Innsbruck, Austria|Kepler University Hospital, Linz, Austria|University Hospital Salzburg, Salzburg, Austria|Hospital Erasme, Brussels, Belgium|CHU de Liege - du Sart Tilman, Liège, Belgium|BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada|The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada|Princess Margaret Cancer Centre, Toronto, Ontario, Canada|CHUM Centre de Recherche, Montréal, Quebec, Canada|Universite de Sherbrooke - Sherbrooke Centre Hospitalier Universita, Sherbrooke, Quebec, Canada|Masaryk Memorial Cancer Institute, Brno, Czechia|University Hospital Plzeñ, Pilsen, Czechia|Na Homolce Hospital, Prague, Czechia|Hospital CHU Nice, Nice, France|Hopital de la Pitie Salpetriere, Paris, France|Institut de Cancerologie de l'Ouest, Saint Herblain, France|Institut Universitaire du Cancer de Toulouse, Toulouse, France|Institut Gusatve Roussy, Villejuif, France|University Hospital Berlin, Berlin, Germany|University Hospital Essen, Essen, Germany|University Hospital Tübingen, Tübingen, Germany|Rambam Medical Center, Haifa, Israel|Rabin Medical Center, Petah Tikva, Israel|Sheba Medical Center, Ramat Gan, Israel|Tel Aviv Sourasky Medical Center, Tel Aviv, Israel|CHUV - Centre Hospitalier Universitaire Vaudois, Department of Clinical Neurosciences and Oncology, Lausanne, Switzerland|University Hospital Zurich, Zürich, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT04471844 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 46: | Study 46: |
| NCT Number: NCT02343549 | |
| Title: A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM) | NCT Number: NCT02343549 |
| Acronym: | |
| Status: Terminated | Title: A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM) |
| Study Results: No Results Available | |
| Conditions: Cancer of Brain and Nervous System | Acronym: |
| Interventions: Device: bevacizumab, NovoTTF100A, temozolomide | |
| Outcome Measures: Survival at 12 months | Status: Terminated |
| Sponsor/Collaborators: Ashley Love Sumrall|NovoCure Ltd.|Atrium Health | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Cancer of Brain and Nervous System |
| Enrollment: 13 | |
| Funded Bys: Other|Industry | Interventions: Device: bevacizumab, NovoTTF100A, temozolomide |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Survival at 12 months |
| Other IDs: LCI-NEU-NOV-001|00010270 | |
| Start Date: January 2015 | Sponsor/Collaborators: Ashley Love Sumrall|NovoCure Ltd.|Atrium Health |
| Primary Completion Date: July 11, 2020 | |
| Completion Date: July 11, 2020 | Gender: All |
| First Posted: January 22, 2015 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: February 3, 2021 | |
| Locations: Levine Cancer Institute, Charlotte, North Carolina, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02343549 | Enrollment: 13 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: LCI-NEU-NOV-001|00010270 |
| | |
| | Start Date: January 2015 |
| | |
| | Primary Completion Date: July 11, 2020 |
| | |
| | Completion Date: July 11, 2020 |
| | |
| | First Posted: January 22, 2015 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: February 3, 2021 |
| | |
| | Locations: Levine Cancer Institute, Charlotte, North Carolina, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02343549 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 47: | Study 47: |
| NCT Number: NCT03488472 | |
| Title: Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain | NCT Number: NCT03488472 |
| Acronym: RAD 1704 | |
| Status: Recruiting | Title: Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain |
| Study Results: No Results Available | |
| Conditions: Brain Metastases|Small Cell Lung Cancer | Acronym: RAD 1704 |
| Interventions: Device: NovoTTF-200A|Radiation: Stereotactic Radiosurgery (SRS) | |
| Outcome Measures: Rate of Distant Metastases|Overall Survival|Local Recurrence|Distant CNS Progression | Status: Recruiting |
| Sponsor/Collaborators: Drexell Hunter Boggs|NovoCure Ltd.|University of Alabama at Birmingham | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years to 99 Years (Adult, Older Adult) | |
| Phases: Not Applicable | Conditions: Brain Metastases|Small Cell Lung Cancer |
| Enrollment: 20 | |
| Funded Bys: Other|Industry | Interventions: Device: NovoTTF-200A|Radiation: Stereotactic Radiosurgery (SRS) |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Rate of Distant Metastases|Overall Survival|Local Recurrence|Distant CNS Progression |
| Other IDs: IRB-300001201 | |
| Start Date: August 9, 2019 | Sponsor/Collaborators: Drexell Hunter Boggs|NovoCure Ltd.|University of Alabama at Birmingham |
| Primary Completion Date: April 2022 | |
| Completion Date: April 2022 | Gender: All |
| First Posted: April 5, 2018 | |
| Results First Posted: | Age: 18 Years to 99 Years (Adult, Older Adult) |
| Last Update Posted: September 17, 2020 | |
| Locations: University of Alabama at Birmingham (UAB), Hazelrig-Salter Radiation Oncology Center (HSROC), Birmingham, Alabama, United States | Phases: Not Applicable |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03488472 | Enrollment: 20 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: IRB-300001201 |
| | |
| | Start Date: August 9, 2019 |
| | |
| | Primary Completion Date: April 2022 |
| | |
| | Completion Date: April 2022 |
| | |
| | First Posted: April 5, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: September 17, 2020 |
| | |
| | Locations: University of Alabama at Birmingham (UAB), Hazelrig-Salter Radiation Oncology Center (HSROC), Birmingham, Alabama, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03488472 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 48: | Study 48: |
| NCT Number: NCT03642080 | |
| Title: MRI Predictors of Response to Tumor Treating Fields | NCT Number: NCT03642080 |
| Acronym: | |
| Status: Recruiting | Title: MRI Predictors of Response to Tumor Treating Fields |
| Study Results: No Results Available | |
| Conditions: Glioblastoma Multiforme | Acronym: |
| Interventions: | |
| Outcome Measures: Progression of disease | Status: Recruiting |
| Sponsor/Collaborators: New York Presbyterian Brooklyn Methodist Hospital | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: | Conditions: Glioblastoma Multiforme |
| Enrollment: 48 | |
| Funded Bys: Other | Interventions: |
| Study Type: Observational | |
| Study Designs: Observational Model: Case-Only|Time Perspective: Prospective | Outcome Measures: Progression of disease |
| Other IDs: 1137708 | |
| Start Date: December 1, 2018 | Sponsor/Collaborators: New York Presbyterian Brooklyn Methodist Hospital |
| Primary Completion Date: September 30, 2021 | |
| Completion Date: December 31, 2023 | Gender: All |
| First Posted: August 22, 2018 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: December 19, 2018 | |
| Locations: New York Presbyterian - Brooklyn Methodist Hospital, Brooklyn, New York, United States | Phases: |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03642080 | Enrollment: 48 |
| | |
| | Funded Bys: Other |
| | |
| | Study Type: Observational |
| | |
| | Study Designs: Observational Model: Case-Only|Time Perspective: Prospective |
| | |
| | Other IDs: 1137708 |
| | |
| | Start Date: December 1, 2018 |
| | |
| | Primary Completion Date: September 30, 2021 |
| | |
| | Completion Date: December 31, 2023 |
| | |
| | First Posted: August 22, 2018 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: December 19, 2018 |
| | |
| | Locations: New York Presbyterian - Brooklyn Methodist Hospital, Brooklyn, New York, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03642080 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 49: | Study 49: |
| NCT Number: NCT03903640 | |
| Title: Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis | NCT Number: NCT03903640 |
| Acronym: | |
| Status: Recruiting | Title: Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis |
| Study Results: No Results Available | |
| Conditions: Melanoma With Brain Metastasis | Acronym: |
| Interventions: Device: Optune|Biological: Nivolumab|Biological: Ipilimumab | |
| Outcome Measures: Intracranial progression-free survival|Overall survival|Best intracranial response rate|Best extracranial response rate|Extracranial progression-free survival|Safety of the treatment regimen as measured by number of treatment-related grade 3 or greater adverse events and discontinuations due to treatment related adverse events. | Status: Recruiting |
| Sponsor/Collaborators: Washington University School of Medicine|NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 2 | Conditions: Melanoma With Brain Metastasis |
| Enrollment: 23 | |
| Funded Bys: Other|Industry | Interventions: Device: Optune|Biological: Nivolumab|Biological: Ipilimumab |
| Study Type: Interventional | |
| Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Intracranial progression-free survival|Overall survival|Best intracranial response rate|Best extracranial response rate|Extracranial progression-free survival|Safety of the treatment regimen as measured by number of treatment-related grade 3 or greater adverse events and discontinuations due to treatment related adverse events. |
| Other IDs: 201903162 | |
| Start Date: July 1, 2019 | Sponsor/Collaborators: Washington University School of Medicine|NovoCure Ltd. |
| Primary Completion Date: January 31, 2024 | |
| Completion Date: July 31, 2027 | Gender: All |
| First Posted: April 4, 2019 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: August 11, 2020 | |
| Locations: Washington University School of Medicine, Saint Louis, Missouri, United States | Phases: Phase 2 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03903640 | Enrollment: 23 |
| | |
| | Funded Bys: Other|Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 201903162 |
| | |
| | Start Date: July 1, 2019 |
| | |
| | Primary Completion Date: January 31, 2024 |
| | |
| | Completion Date: July 31, 2027 |
| | |
| | First Posted: April 4, 2019 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: August 11, 2020 |
| | |
| | Locations: Washington University School of Medicine, Saint Louis, Missouri, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03903640 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 50: | Study 50: |
| NCT Number: NCT03203525 | |
| Title: Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer | NCT Number: NCT03203525 |
| Acronym: | |
| Status: Recruiting | Title: Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer |
| Study Results: No Results Available | |
| Conditions: Advanced Malignant Neoplasm|Colorectal Carcinoma Metastatic in the Liver|Metastatic Malignant Neoplasm in the Liver|Refractory Malignant Neoplasm | Acronym: |
| Interventions: Biological: Bevacizumab|Drug: Fluorouracil|Drug: Leucovorin|Drug: Oxaliplatin|Drug: Pegylated Liposomal Doxorubicin Hydrochloride|Drug: Temsirolimus|Procedure: Tumor Treating Fields Therapy | |
| Outcome Measures: Incidence of adverse events|Response|Biomarker analysis | Status: Recruiting |
| Sponsor/Collaborators: M.D. Anderson Cancer Center|National Cancer Institute (NCI) | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Advanced Malignant Neoplasm|Colorectal Carcinoma Metastatic in the Liver|Metastatic Malignant Neoplasm in the Liver|Refractory Malignant Neoplasm |
| Enrollment: 52 | |
| Funded Bys: Other|NIH | Interventions: Biological: Bevacizumab|Drug: Fluorouracil|Drug: Leucovorin|Drug: Oxaliplatin|Drug: Pegylated Liposomal Doxorubicin Hydrochloride|Drug: Temsirolimus|Procedure: Tumor Treating Fields Therapy |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Incidence of adverse events|Response|Biomarker analysis |
| Other IDs: 2014-0357|NCI-2018-01597|P30CA016672 | |
| Start Date: June 23, 2020 | Sponsor/Collaborators: M.D. Anderson Cancer Center|National Cancer Institute (NCI) |
| Primary Completion Date: December 31, 2021 | |
| Completion Date: December 31, 2021 | Gender: All |
| First Posted: June 29, 2017 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: August 12, 2020 | |
| Locations: M D Anderson Cancer Center, Houston, Texas, United States | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT03203525 | Enrollment: 52 |
| | |
| | Funded Bys: Other|NIH |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: 2014-0357|NCI-2018-01597|P30CA016672 |
| | |
| | Start Date: June 23, 2020 |
| | |
| | Primary Completion Date: December 31, 2021 |
| | |
| | Completion Date: December 31, 2021 |
| | |
| | First Posted: June 29, 2017 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: August 12, 2020 |
| | |
| | Locations: M D Anderson Cancer Center, Houston, Texas, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT03203525 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 51: | Study 51: |
| NCT Number: NCT01756729 | |
| Title: Post-approval Study of NovoTTF-100A in Recurrent GBM Patients | NCT Number: NCT01756729 |
| Acronym: | |
| Status: Terminated | Title: Post-approval Study of NovoTTF-100A in Recurrent GBM Patients |
| Study Results: No Results Available | |
| Conditions: Recurrent Glioblastoma Multiforme | Acronym: |
| Interventions: Device: NovoTTF-100A | |
| Outcome Measures: Overall Survival|Change in neuro-cognitive function from baseline based on MMSE|Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment|Adverse events severity and frequency | Status: Terminated |
| Sponsor/Collaborators: NovoCure Ltd. | |
| Gender: All | Study Results: No Results Available |
| Age: 22 Years and older (Adult, Older Adult) | |
| Phases: Phase 4 | Conditions: Recurrent Glioblastoma Multiforme |
| Enrollment: 13 | |
| Funded Bys: Industry | Interventions: Device: NovoTTF-100A |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Overall Survival|Change in neuro-cognitive function from baseline based on MMSE|Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment|Adverse events severity and frequency |
| Other IDs: EF-19 | |
| Start Date: December 2012 | Sponsor/Collaborators: NovoCure Ltd. |
| Primary Completion Date: January 2018 | |
| Completion Date: January 2018 | Gender: All |
| First Posted: December 27, 2012 | |
| Results First Posted: | Age: 22 Years and older (Adult, Older Adult) |
| Last Update Posted: March 2, 2016 | |
| Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States|Barrow Neurology Clinics, Phoenix, Arizona, United States|University of California San Diego Moores Cancer Center, La Jolla, California, United States|Keck Medical Center of USC, Los Angeles, California, United States|Sylvester Comprehensive Cancer Center, Miami, Florida, United States|University of Illinois at Chicago, Chicago, Illinois, United States|University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Washington University School of Medicine, Division of Oncology, St. Louis, Missouri, United States|The Long Island Brain Tumor Center, Lake Success, New York, United States|Geisinger Health System, Danville, Pennsylvania, United States|Baylor Research Institute, Dallas, Texas, United States | Phases: Phase 4 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT01756729 | Enrollment: 13 |
| | |
| | Funded Bys: Industry |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: EF-19 |
| | |
| | Start Date: December 2012 |
| | |
| | Primary Completion Date: January 2018 |
| | |
| | Completion Date: January 2018 |
| | |
| | First Posted: December 27, 2012 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: March 2, 2016 |
| | |
| | Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States|Barrow Neurology Clinics, Phoenix, Arizona, United States|University of California San Diego Moores Cancer Center, La Jolla, California, United States|Keck Medical Center of USC, Los Angeles, California, United States|Sylvester Comprehensive Cancer Center, Miami, Florida, United States|University of Illinois at Chicago, Chicago, Illinois, United States|University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Washington University School of Medicine, Division of Oncology, St. Louis, Missouri, United States|The Long Island Brain Tumor Center, Lake Success, New York, United States|Geisinger Health System, Danville, Pennsylvania, United States|Baylor Research Institute, Dallas, Texas, United States |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT01756729 |
| | |
| | |
| | |
| | <WRAP center box 98%> |
| |
| Study 52: | Study 52: |
| NCT Number: NCT02903069 | |
| Title: Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer | NCT Number: NCT02903069 |
| Acronym: | |
| Status: Active, not recruiting | Title: Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer |
| Study Results: No Results Available | |
| Conditions: Glioblastoma|Malignant Glioma | Acronym: |
| Interventions: Drug: MRZ|Drug: TMZ|Radiation: RT|Device: Optune | |
| Outcome Measures: Determine MRZ maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for both concomitant treatment (MRZ + TMZ + RT) and adjuvant treatment (MRZ + TMZ)|To assess adverse events during the adjuvant treatment|To confirm the MRZ RP2D for concomitant and adjuvant treatment in an expanded group of patients|Assess adverse events during concomitant and adjuvant treatment|Evaluate the activity (overall survival [OS]) of MRZ + TMZ + RT|Evaluate the activity (progression-free survival [PFS]) of MRZ + TMZ + RT|MRZ pharmacokinetics - Maximum Serum Concentration (Cmax)|MRZ pharmacokinetics - Elimination Half-Life (t1/2)|MRZ pharmacokinetics - Area Under the Blood Concentration-Time Curve (AUC0-t, AUC0-inf)|MRZ pharmacokinetics - Clearance (CL)|MRZ pharmacokinetics - Volume of Distribution (Vd)|TMZ serum concentration|Assess neurological coordination using the Scale for the Assessment and Rating for Ataxia (SARA)|Evaluate the activity (overall survival [OS]) of MRZ + TMZ + Optune|Evaluate the activity (progression-free survival [PFS]) of MRZ + TMZ + Optune | Status: Active, not recruiting |
| Sponsor/Collaborators: Celgene|Triphase | |
| Gender: All | Study Results: No Results Available |
| Age: 18 Years and older (Adult, Older Adult) | |
| Phases: Phase 1 | Conditions: Glioblastoma|Malignant Glioma |
| Enrollment: 66 | |
| Funded Bys: Industry|Other | Interventions: Drug: MRZ|Drug: TMZ|Radiation: RT|Device: Optune |
| Study Type: Interventional | |
| Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment | Outcome Measures: Determine MRZ maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for both concomitant treatment (MRZ + TMZ + RT) and adjuvant treatment (MRZ + TMZ)|To assess adverse events during the adjuvant treatment|To confirm the MRZ RP2D for concomitant and adjuvant treatment in an expanded group of patients|Assess adverse events during concomitant and adjuvant treatment|Evaluate the activity (overall survival [OS]) of MRZ + TMZ + RT|Evaluate the activity (progression-free survival [PFS]) of MRZ + TMZ + RT|MRZ pharmacokinetics - Maximum Serum Concentration (Cmax)|MRZ pharmacokinetics - Elimination Half-Life (t1/2)|MRZ pharmacokinetics - Area Under the Blood Concentration-Time Curve (AUC0-t, AUC0-inf)|MRZ pharmacokinetics - Clearance (CL)|MRZ pharmacokinetics - Volume of Distribution (Vd)|TMZ serum concentration|Assess neurological coordination using the Scale for the Assessment and Rating for Ataxia (SARA)|Evaluate the activity (overall survival [OS]) of MRZ + TMZ + Optune|Evaluate the activity (progression-free survival [PFS]) of MRZ + TMZ + Optune |
| Other IDs: MRZ-112 | |
| Start Date: August 17, 2016 | Sponsor/Collaborators: Celgene|Triphase |
| Primary Completion Date: February 26, 2021 | |
| Completion Date: February 26, 2021 | Gender: All |
| First Posted: September 16, 2016 | |
| Results First Posted: | Age: 18 Years and older (Adult, Older Adult) |
| Last Update Posted: March 9, 2021 | |
| Locations: University of California San Diego Medical Center, La Jolla, California, United States|UC Irvine, Orange, California, United States|John Wayne Cancer Center Outpatient Clinic, Santa Monica, California, United States|Northwestern Center For Clinical Research, Chicago, Illinois, United States|Duke Cancer Center, Durham, North Carolina, United States|Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States|Princess Margaret Cancer Centre, Toronto, Ontario, Canada|University of Zurich Hospital, Zurich, Switzerland | Phases: Phase 1 |
| Study Documents: | |
| URL: https://ClinicalTrials.gov/show/NCT02903069 | Enrollment: 66 |
| | |
| | Funded Bys: Industry|Other |
| | |
| | Study Type: Interventional |
| | |
| | Study Designs: Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| | |
| | Other IDs: MRZ-112 |
| | |
| | Start Date: August 17, 2016 |
| | |
| | Primary Completion Date: February 26, 2021 |
| | |
| | Completion Date: February 26, 2021 |
| | |
| | First Posted: September 16, 2016 |
| | |
| | Results First Posted: |
| | |
| | Last Update Posted: March 9, 2021 |
| | |
| | Locations: University of California San Diego Medical Center, La Jolla, California, United States|UC Irvine, Orange, California, United States|John Wayne Cancer Center Outpatient Clinic, Santa Monica, California, United States|Northwestern Center For Clinical Research, Chicago, Illinois, United States|Duke Cancer Center, Durham, North Carolina, United States|Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States|Princess Margaret Cancer Centre, Toronto, Ontario, Canada|University of Zurich Hospital, Zurich, Switzerland |
| | |
| | Study Documents: |
| | |
| | </WRAP> |
| | |
| | URL: https://ClinicalTrials.gov/show/NCT02903069 |
| |
| |
| |
| </text> | |
| |
