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NRG-BN001

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/Co-Principal Investigator

Minesh Mehta, MD/Vinai Gondi, MD 

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). 

Please note this trial is available to non-proton centers.   

Target Accrual

576 randomized patients (288 Group I, 288 Group II)  

Status

Activated October 27, 2014

Protocol Documents

  • The protocol and related documents are available at NRG-BN001
  • A letter from NCI to insurance providers regarding coverage for proton therapy is available here.
  • A slide set overview of this trial is available here.

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Copyright 2017 by NRG Oncology