Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .

PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Cisplatin; Fluorouracil; Mitomycin; Mitomycins

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell anal carcinoma

• Keratinizing or non-keratinizing

• The following stages are eligible:

• T2, N0, M0 with maximum tumor diameter at least 4 cm

• T3-T4, N0, M0

• Any T, N1-N3, M0

• Tumor located in the anal canal OR in the anal margin and infiltrating the anal canal

• No primary adenocarcinoma of the anus

• Measurable disease

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count greater than 2,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• Not specified

Renal

• Creatinine less than 1.4 mg/dL

Cardiovascular

• No grade I angina pectoris with clinical symptoms within the past 3 months

• No grade II-IV angina pectoris within the past 3 months

• No stage II or greater distal arteritis

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

• No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No other concurrent radiotherapy

Surgery

• No prior colostomy

Other

• No prior treatment for anal cancer