PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA
16 Years
69 Years
Both
Brain and Central Nervous System Tumors
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Newly diagnosed oligodendroglioma or oligoastrocytoma (with at
least 25% oligodendral elements) Low-grade oligodendroastrocytoma or oligodendroglioma
that is recurrent after surgery without radiotherapy is allowed Prior partial or gross
total resection of tumor (or biopsy only in case of no further surgical option) required
At least 3 of the following histologic anaplastic features: High cellularity Endothelial
abnormalities Nuclear abnormalities Necrosis Mitoses
PATIENT CHARACTERISTICS: Age: 16 to 69 Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.4 mg/dL Renal: Creatinine no greater than 1.3 mg/dL
Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients
must use effective contraception No active or uncontrolled infection No other disease,
including malignancy, that would preclude study No neurologic or psychiatric disturbance
that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No
prior radiotherapy to the skull Surgery: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Martin J. van Den Bent, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-26951
NCT ID:
NCT00002840
Start Date:
August 1996
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult anaplastic oligodendroglioma
- adult mixed glioma
- Nervous System Neoplasms
- Oligodendroglioma
- Central Nervous System Neoplasms
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