|Protocol No.||NRG-BN001||Principal Investigator||Mishra, Mark
|Phase||Phase II (Cancer Control)
|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
|Treatment|| Radiation: 3-dimensional conformal radiation therapy; intensity-modulated radiation ; proton beam radiation therapy
|Key Eligibility||Inclusion Criteria STEP 1:
1. A diagnostic contrast-enhanced MRI (no other scan type allowed) of the brain must be performed postoperative.
2. Tumor tissue must be available for submission for central pathology review.
3. The tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed).
4. Patients must provide study-specific informed consent prior to step 1 registration.
Inclusion Criteria STEP 2:
5. Histologically proven diagnosis of glioblastoma (WHO grade IV) confirmed by central review prior to step 2 registration.
6. Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient quantity for analysis of MGMT status.
7. History/physical examination within 28 days prior to step 2 registration.
8. The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days prior to step 2 registration.
9. Documentation of steroid doses within 28 days prior to step 2 registration.
10. Karnofsky performance status greater than or equal to 70 within 28 days prior to step 2 registration.
11. Age greater than or equal to 18.
12. CBC/differential obtained within 28 days prior to step 2 registration, with adequate bone marrow function.
13. Adequate hepatic function within 28 days prior to step 2 registration.
14. Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration.
*For exclusion criteria information please, call study site contact.*
|Applicable Disease Sites||Brain and Nervous System
|Contact||Greenebaum Cancer Center Caroline Poff, MS, R.N.||