NRG-BN001

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

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

576