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

• Status: Completed
• Trial end date: 2007-03-31
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven nonmetastatic anal cancer

• Anal/rectal junction OR

• Anal/cutaneous junction with the majority of the tumor in the anal canal, above the junction

• Epidermoid cancer (well-differentiated, fairly differentiated, or basaloid) OR

• Cloacogenic cancer

• Stage II or III

• T2 at least 4 cm OR

• T3 OR

• T4, N0-3, M0 OR

• T1, N1-3 OR

• T2 (less than 4 cm), N1-3

• Tumors at least 4 cm in greatest dimension and/or tumors with lymph node invasion must be nonmetastatic by ultrasound

• No prior surgery to remove tumor

PATIENT CHARACTERISTICS:

Age:

• 80 and under

Performance status:

• WHO 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 11 g/dL (transfusion allowed)

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No cardiac condition contraindicating use of fluorouracil

Other:

• No prior malignancy within 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or breast

• No other serious medical or psychological condition

• No serious immunosuppression

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No prior endocrine therapy

Radiotherapy:

• No prior pelvic or inguinal radiotherapy

Surgery:

• See Disease Characteristics

• No prior definitive colostomy