Radiation Therapy with or without Temozolomide in Treating Patients with Anaplastic Glioma

Inclusion Criteria

• AT THE TIME OF REGISTRATION: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis
• AT THE TIME OF REGISTRATION: Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
• AT THE TIME OF REGISTRATION: Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
• AT THE TIME OF REGISTRATION: World Health Organization (WHO) performance status 0-2
• AT THE TIME OF REGISTRATION: Age >= 18 years
• AT THE TIME OF REGISTRATION: All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
• AT THE TIME OF REGISTRATION: Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection
• AT THE TIME OF REGISTRATION: Absence of any other serious medical condition that can interfere with follow-up
• AT THE TIME OF REGISTRATION: Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
• AT THE TIME OF REGISTRATION: No previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to registration, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
• AT THE TIME OF REGISTRATION: Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• AT THE TIME OF REGISTRATION: No prior chemotherapy (including no treatment with carmustine [BCNU] containing wafers [Gliadel])
• AT THE TIME OF REGISTRATION: No prior radiotherapy to the brain
• AT THE TIME OF REGISTRATION: Before patient registration, written informed consent must be obtained, according to International Conference on Harmonisation/Good Clinical Practice (ICH/GCP), and national/local regulations
• RANDOMIZATION STEP: The combination of: * Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis AND * Absence of combined 1p/19q loss Both of which must have been determined by either local testing or central review
• RANDOMIZATION STEP: Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
• RANDOMIZATION STEP: WHO performance status 0-2
• RANDOMIZATION STEP: Age >= 18 years
• RANDOMIZATION STEP: Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
• RANDOMIZATION STEP: Start of radiotherapy within 8 days from randomization
• RANDOMIZATION STEP: Start of radiotherapy within 7 weeks (49 days) from surgery (extra 2 days could be allowed)
• RANDOMIZATION STEP: Patients must be on a stable or decreasing dose of steroids for at least two weeks
• RANDOMIZATION STEP: No prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel)
• RANDOMIZATION STEP: No prior radiotherapy to the brain
• RANDOMIZATION STEP: No concomitant treatment with other anti-cancer agents or with any other experimental agent
• RANDOMIZATION STEP: Neutrophils greater or equal to 1.5*10^9 cells/l (to be performed within 28 days prior to randomization)
• RANDOMIZATION STEP: Platelets greater or equal to 100*10^9 cells/l (to be performed within 28 days prior to randomization)
• RANDOMIZATION STEP: Bilirubin < 1.5 times upper limit of laboratory normal (to be performed within 28 days prior to randomization)
• RANDOMIZATION STEP: Alkaline phosphatase, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 2.5 times upper limit of laboratory normal (to be performed within 28 days prior to randomization)
• RANDOMIZATION STEP: Serum creatinine lower than 1.5 times upper limit of laboratory normal (to be performed within 28 days prior to randomization)
• RANDOMIZATION STEP: All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
• RANDOMIZATION STEP: Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
• RANDOMIZATION STEP: Absence of any other serious medical condition that could interfere with follow-up
• RANDOMIZATION STEP: Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
• RANDOMIZATION STEP: Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• RANDOMIZATION STEP: Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
• RANDOMIZATION STEP: Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable