Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI); North Central Cancer Treatment Group; Southwest Oncology Group
• Treatments: Cisplatin; Fluorouracil; Mitomycin; Mitomycins

Criteria

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