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Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma


Title 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
Therapeutic Area Brain Tumors, Glioblastoma
Principal Investigator John Mignano, MD
Min Age 18 Years
Gender Both
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT02179086

Overview

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

Study Details

Inclusion Criteria

  • Newly diagnosed glioblastoma (GBM)
  • Otherwise normal organ function

Exclusion Criteria

  • No pregnant or nursing women
  • No prior history of other cancers, unless cancer free for more than 3 years. No prior history at all of brain or head and neck cancers.
  • No pacemakers or other reasons to be unable to have an MRI.

Study Requirements

After surgery, all subjects will come to the hospital for a clinic visit and screening tests to ensure they are eligible to be in the study. If they agree, subjects’ blood and urine samples will be collected and sent to the NRG BioBank for future research studies into cancer or other medical conditions. Once in the study, subjects will come to the clinic for radiation 5 days a week for 6 weeks. This is the standard schedule for radiation for newly diagnosed GBM. One third of subjects will receive the standard dose of radiation, 60 cGy. Two thirds of subjects will receive a higher, experimental, dose of radiation, 75 cGy. During and after radiation, all subjects will receive the standard chemotherapy, temozolomide. Adjuvant chemtherapy (chemotherapy after radiation) will last 6-12 months.