EF-32 (TRIDENT): A Pivotal Randomized, open-label study of Optune (TTFields, 200kHz) concomitant with radiation therapy and temozolomide for the treatment of newly diagnosed glioblastoma (Brain Tumors)
Study of Tumor Treating Fields (Optune, 200kHz) with Radiation Therapy and Temozolomide for Treatment of Newly Diagnosed Glioblastoma
Sponsor: Novocure
Enrolling: Male and Female Patients
IRB Number: AAAT2296
U.S. Govt. ID: NCT04471844
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: Optune is a portable, battery-operated device that generates TTFields at a specific frequency. The TTFields are delivered to the brain through 4 sticky bandages (which hold ceramic discs) that are placed on the surface of the head (called arrays). The arrays create electric forces within the brain that disrupt cancer cell division. Optunes TTFields are a novel type of cancer treatment that has been shown in laboratory studies to slow the growth of tumors, without causing significant side effects. In addition, the use of TTFields as a cancer treatment has been tested in numerous studies of participants with GBM brain cancer. Based on the results of these studies, Optune is approved for the treatment of GBM in many countries, including the United States. The purpose of the current research study is to test if the addition of Optune at the time will improve clinical outcomes compared to the approved use of Optune. It is planned that 950 subjects with a new diagnosis of GBM and who are planned to have radiation therapy with temozolomide, will participate in this study after surgery or biopsy.
This study is closed
Fabio Iwamoto, MD
Do You Qualify?
Are you 22 years of age or older? Yes No
Do you have a confirmed diagnosis of tissue based glioblastoma? Yes No
Are you willing to provide tumor tissue after surgery or biopsy? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Research Nurse Navigator