Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

Inclusion criteria

• Histopathologically proven diagnosis of glioblastoma. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.
• Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged.
• Diagnosis must be established by open biopsy or tumor resection. Patients who have only had a stereotactic biopsy are not eligible.
• The tumor must have a supratentorial component.
• Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration.
• A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computerized tomography (CT) scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively. The postoperative scan must be done within 28 days of registration and prior to the initiation of radiotherapy. Preoperative and postoperative scans must be the same type. If CT scans were performed perioperatively, a CT and an MRI should be performed before randomization.

6.1. Patients unable to undergo MRI imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.

• Therapy must begin ≤ 5 weeks after the most recent brain tumor surgery.
• History/physical examination within 14 days prior to study registration.
• Neurologic examination within 14 days prior to study registration.
• Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration.
• Karnofsky performance status of ≥ 60.
• Age ≥ 18 years.
• Complete blood count (CBC)/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below: 13.1 Absolute neutrophil count (ANC) ≥ 1500 cells/mm3. 13.2 Platelets ≥ 100,000 cells/mm3. 13.3 Hemoglobin ≥ 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
• Adequate renal function, as defined below:

14.1 Blood urea nitrogen (BUN) ≤ 25 mg/dl within 14 days prior to study registration 14.2 Creatinine ≤ 1.7 mg/dl within 14 days prior to study registration

• Adequate hepatic function, as defined below:

15.1 Bilirubin ≤ 2.0 mg/dl within 14 days prior to study registration 15.2 Alanine aminotransferase (ALT) ≤ 3 x normal range within 14 days prior to study registration 15.3 Aspartate aminotransferase (AST) ≤ 3 x normal range within 14 days prior to study registration

• Patients must sign a study-specific informed consent prior to study registration.

If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member.

• For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide.
• Women of childbearing potential and male participants must practice adequate

Exclusion criteria

• Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
• Recurrent or multifocal malignant gliomas
• Metastases detected below the tentorium or beyond the cranial vault.
• Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. See Section 1.
• Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
• Severe, active co-morbidity, defined as follows:
• 6.1. Unstable angina and/or congestive heart failure requiring hospitalization.
• 6.2. Transmural myocardial infarction within the last 6 months.
• 6.3. Acute bacterial