Preoperative Chemoradiation for Glioblastoma

Prior to any definitive treatment and after enrollment, the patient will undergo
stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine
methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic
technique will be used. Patients will be treated with conformal radiation therapy.
Temozolomide will be given from the day prior to radiation therapy through the last day of
radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and
maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.

Imaging:

MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation
therapy and prior to surgery. MRI within 48 hours after surgery.

MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2
years.

Inclusion Criteria:

- MRI lesions of the brain that have a high probability of being glioblastoma in a
potentially resectable location in the brain (the primary study population)

- WHO performance status 0-2 (to allow comparison to historical controls)

- Adequate hematological parameters: (for safety because of neutropenia from the
temozolomide)

- Consent can be obtained from the patient, and if the patient cannot give consent then
from the medical power of attorney and if one is not assigned, then the nearest
relative (required to obtain consent)

- Able to have MRI scans (secondary endpoint is MRI scan characteristics)

- Willing to have radiation treatment at a participating center (homogeneity of
treatment parameters)

- Ages 18-80

Exclusion Criteria:

- Unresectable tumor

- Absolute neutrophil count (ANC) less than 1,200/μL

- Hemoglobin less than 9.0g/dL

- Platelet count less than 100,000/μL