Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
Principal Investigator
Minesh Mehta, MD
Status
Closed to Accrual
Date Opened To Accrual
October 27 2014
Date Closed to Accrual
May 11 2022
Disease Site
Brain [BN]
Malignant Glioma
Phase
II
Developmental Therapeutics
No
Primary Objective
To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves overall survival, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide.
Patient Population
Histologically proven diagnosis of glioblastoma (WHO grade IV) confirmed by central review prior to step 2 registration. Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient quantity for analysis of MGMT status. The tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed).
Target Accrual
569
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.