PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA
OBJECTIVES: I. Compare survival and time to first progression in patients with anaplastic
oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine,
lomustine, and vincristine (PCV) following surgical resection. II. Investigate the effect of
PCV on quality of life and neurologic function in these patients. III. Determine the
toxicity of PCV in these patients. IV. Correlate chromosomal lesions (1p and/or 19q, 9p, p53
loss and mutation, amplification of chromosome 7, or loss of chromosome 10) with
progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age,
extent of resection, performance status, prior surgery, and participating center. Patients
are randomized to one of two treatment arms. Arm I: Within 4-6 weeks after surgery, patients
undergo radiotherapy over 7 weeks to the residual tumor volume. Arm II: Patients undergo
radiotherapy as in arm I, then begin chemotherapy within 4 weeks after the completion of
radiotherapy. Patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and
vincristine IV on days 8 and 29. Treatment repeats every 6 weeks in stable and responding
patients for a total of 6 courses. Patients with disease recurrence may receive 6 additional
courses of chemotherapy as above or another modality at the investigator's discretion.
Patients are followed every 3 months for 1 year and then every 6 months for survival.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
Allocation: Randomized, Primary Purpose: Treatment
Martin J. van Den Bent, MD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government