Clinical Trial 21039

Study Title

A Pivotal Randomized, Open-Label Study Of OPTUNE(R)(TTFIELDS, 200KHZ) Concomitant With Radiation Therapy And Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma

Summary

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.

Objective

Primary Objective: To determine if TTFields treatment at 200 kHz to the brain concomitantly with RT and TMZ in the treatment of GBM patients prolongs the overall survival of patients, compared to RT and TMZ treatments followed by TTFields and maintenance TMZ. Secondary Objectives: To determine if TTFields at 200 kHz to the brain concomitant with RT+ TMZ in the treatment of newly diagnosed GBM patients prolongs the progression-free survival of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ To determine if TTFields at 200 kHz to the brain concomitant with RT+ TMZ in the treatment of newly diagnosed GBM patients increases the 1- and 2-year survival rates of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ. To determine if TTFields at 200 kHz to the brain concomitant with RT TMZ in the treatment of newly diagnosed GBM patients improves the overall radiological response rate of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ. To determine if TTFields at 200 kHz to the brain concomitant with RT + TMZ in the treatment of newly diagnosed GBM patients prolongs the next progression-free survival (PFS2) of patients, compared to RT + TMZ followed by TTFields + maintenance TMZ. To determine if TTFields at 200 kHz to the brain concomitant with RT+ TMZ in the treatment of newly diagnosed GBM patients increases the progression-free survival rate at 6 and 12 months, compared to RT + TMZ followed by TTFields + maintenance TMZ. To compare severity and frequency of adverse events of TTFields at 200 kHz to the brain concomitant with RT + TMZ in the treatment of newly diagnosed GBM patients to that of treatment with RT + TMZ followed by TTFields + maintenance TMZ. To describe potential pathological changes in GBM tumors following the treatment of patients treated with TTFields at 200 kHz to the brain concomitant with RT + TMZ followed by TTFields + maintenance TMZ. To compare Quality of Life using the EORTC QLQ C30 (with BN20 module) of TTFields at 200 kHz to the brain concomitant with RT + TMZ in the treatment of newly diagnosed GBM patients to that of treatment with RT + TMZ followed by TTFields + maintenance TMZ. To explore if TTFields at 200 kHz prolongs overall survival in a dose dependent-manner, i.e. to explore the possible connection between higher doses of TTFields at the tumor bed and longer patient survival. NANO scale: To compare neurologic function of TTFields at 200 kHz to the brain concurrent with RT + TMZ in the treatment of newly diagnosed GBM patients to the of treatment with RT + TMZ followed by TTFields + maintenance TMZ using the NANO scale.