Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
 Combining chemotherapy with radiation therapy may kill more tumor cells.

 PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or
 without chemotherapy in treating patients who have anaplastic oligodendroglioma.
OBJECTIVES:

 -  Compare the overall survival and time to tumor progression in patients with unifocal or
 multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with
 radiotherapy with or without procarbazine, lomustine, and vincristine (PCV).

 -  Compare the toxic effects of these 2 regimens in these patients.

 -  Compare the quality of life and neurologic function of patients treated with these 2
 regimens.

 OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and
 over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs
 highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of
 2 treatment arms.

 -  Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1,
 oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment
 continues every 6 weeks for 4 courses in the absence of disease progression or
 unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients
 undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a
 week for 1 week.

 -  Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I.

 Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3
 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually
 thereafter after completion of study therapy.

 Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
 for 3 years, and then annually thereafter.

 PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study
 within 5.4 years.
DISEASE CHARACTERISTICS:

 -  Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic
 oligodendroglioma

 -  Prior suspected or proven low-grade glioma allowed if current histologic proof of
 pure or mixed anaplastic oligodendroglioma

 -  Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2
 or more anaplastic features, 1 of which must be frequent mitoses or endothelial
 proliferation

 -  For mixed tumors, the non-oligodendroglial element must be astrocytic and the
 oligodendroglial or astroglial component may be anaplastic

 -  No evidence of spinal drop metastasis or spread to noncontiguous meninges

 -  MRI of spine not required for asymptomatic patients and patients not excluded
 based on pathologic evidence of local meningeal infiltration by underlying tumor

 -  No tumor that is predominantly located in the posterior fossa (i.e., brainstem or
 cerebellum)

 -  No spinal cord tumors

 PATIENT CHARACTERISTICS:

 Age:

 -  18 and over

 Performance status:

 -  Karnofsky 60-100%

 Life expectancy:

 -  Not specified

 Hematopoietic:

 -  Absolute granulocyte count at least 1,500/mm^3

 -  Platelet count at least 150,000/mm^3

 Hepatic:

 -  Bilirubin no greater than 2 times normal

 -  Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal

 -  Alkaline phosphatase no greater than 2 times normal

 Renal:

 -  Creatinine no greater than 1.5 times normal

 Pulmonary:

 -  No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO)
 is at least 60% predicted

 Other:

 -  No active infection

 -  No other malignancy within the past 5 years except nonmelanomatous skin cancer or
 carcinoma in situ of the cervix

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  Not specified

 Chemotherapy:

 -  No prior chemotherapy

 Endocrine therapy:

 -  No concurrent steroids as antiemetics

 -  Concurrent steroids allowed to control central nervous system (CNS) symptoms due to
 tumor-associated or radiotherapy-associated cerebral edema

 Radiotherapy:

 -  No prior radiotherapy to brain or head/neck

 Surgery:

 -  Prior surgery allowed