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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug or combining radiation therapy
with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and
mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus
radiation therapy for anal cancer.
PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus
radiation therapy to see how well it works compared to fluorouracil and cisplatin plus
radiation therapy in treating patients with stage II or stage III anal cancer.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, other than carcinoma in situ - T2-4, Any N, M0 (stage II or III) - No local or regional recurrence after local excision or abdominal peritoneal resection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Absolute neutrophil count at least 1,800/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than 1.4 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 80 mL/min Cardiovascular: - No uncompensated heart disease - No uncontrolled high blood pressure Other: - No AIDS - No active systemic infection - No uncontrolled diabetes - No other prior malignancy within the past 5 years except nonmelanoma skin cancer - No mental condition that would preclude study participation - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior epoetin alfa allowed in lieu of blood transfusions Chemotherapy: - At least 5 years since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 5 years since prior radiotherapy Surgery: - No prior surgery of anal canal except for biopsy of study site
Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00003596
Not Accepting Healthy Volunteers