Ef-32: Pivotal, Randomized, Open-Label Study Of Optune® (Tumor Treating Fields, 200Khz) Concomitant With Radiation Therapy And Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma
Posted Date: May 20, 2021
- Investigator: Kyle Wang
- Specialties: Cancer, Oncology
- Type of Study: Device & Drug
The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. Effectiveness will be determined by measuring Overall Survival Rate.
Criteria:
Must Have Confirmed Diagnosis Of Gbm, Planned Treatment With Rt/Tmz Followed By Ttfields And Maintenance Tmz, Karnofsky Performance Status = 70, Life Expectancy = Least 3 Months, No Progressive Disease, No Significant Co-Morbidities At Baseline Which Would Preclude Maintenance Rt Or Tmz Treatment, As Determined By The Investigator, No Implanted Pacemaker, Defibrillator, Deep Brain Stimulator, Other Implanted Electronic Devices In The Brain, Or Documented Clinically Significant Arrhythmias, No Evidence Of Increased Intracranial Pressure, No Skull Defects
Keywords:
Glioblastoma, Gbm, Radiation
For More Information:
Uc Cancer Center
513-584-7698
cancer@uchealth.com