Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03705351|
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Cancer of Brain Glioblastoma Multiforme Brain Tumor||Device: Tumor Treating Fields Drug: Temozolomide Radiation: Radiation Therapy||Phase 1|
The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.
The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months.
Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||The study is an open-label pilot study. Following surgery, eligible patients will start tumor treating fields therapy with the Optune device less than 2 weeks prior to radiation and temozolomide given at a dose and schedule conforming to routine treatment.|
|Masking:||None (Open Label)|
|Official Title:||Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)|
|Actual Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||November 1, 2023|
|Estimated Study Completion Date :||November 1, 2025|
Patients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy.
Device: Tumor Treating Fields
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.
Patients will be given temozolomide according to routine treatment dosing and schedule.
Other Name: Temodar
Radiation: Radiation Therapy
Patients will be given radiation therapy according to routine treatment dosing and schedule.
- Rate of treatment-related adverse events associated with trimodal therapy [ Time Frame: 15 weeks (8 weeks after completion of trimodal therapy) ]Number of patients who experienced a treatment-related adverse event
- Severity of treatment-related adverse events associated with trimodal therapy [ Time Frame: 15 weeks (8 weeks after completion of trimodal therapy) ]Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)
- Progression-free survival at 6 months and 24 months [ Time Frame: 24 months ]Number of patients who are progression free at 6 months and 24 months
- Overall Survival Rate [ Time Frame: 24 months ]Number of patients alive at 24 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705351
|Contact: Tiffany Gervasi-Follmar||503-216-1023||Tiffany.Gervasi-Follmar@providence.org|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Juan Valderramos 415-353-2167 Juan.valderramos@UCSF.edu|
|United States, Oregon|
|Providence St. Vincent Medical Center||Recruiting|
|Portland, Oregon, United States, 97225|
|Contact: Lynette Currie 503-216-1034 Lynette.Currie@providence.org|
|Principal Investigator:||Ricky Chen, MD||Providence Health and Services|