Neurologic Cancer 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

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.

Eligibility Criteria:

1. Histologically confirmed diagnosis of GBM (WHO)
2. Age ≥ 22 years in US ( > 18 years in ROW)
3. Karnofsky performance status ≥ 70, Life expectancy ≥ 3 months
4. Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
5. No Infratentorial or leptomeningeal disease
6. No other Implanted devices
7. No Evidence of increased intracranial pressure

This study is for patients age 18 and older.

Available at: Hartford Hospital, Midstate Medical Center, William Backus Hospital.