RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy combined with fluorouracil and cisplatin in treating patients who have stage II or stage III bladder cancer, and who have undergone transurethral resection.

OBJECTIVES: I. Evaluate the rate of severe acute toxicity occurring during therapy with accelerated external radiotherapy with concurrent fluorouracil (5-FU) and cisplatin following transurethral resection of the bladder in patients with stage II or III muscle invasive transitional cell carcinoma of the bladder. II. Evaluate the rate of freedom from local recurrence to this combined therapy assessed 3 months after the end of treatment in these patients. III. Assess the feasibility of this new therapeutic approach in this patient population. IV. Determine the overall recurrent free survival, long term side effects, and overall survival in these patients.

PROTOCOL OUTLINE: This is an open label, multicenter study. Patients undergo accelerated external radiotherapy twice daily 5 days a week for 5 weeks. Concurrent chemotherapy is administered on the first and fifth week consisting of cisplatin IV over 2 hours daily and fluorouracil by 24 hour continuous infusion daily on days 1-5. Patients are followed at 3 months, then every 3 months for the first 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 19-43 patients accrued into this study.

Ages Eligible for Study:  up to  75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed unifocal or multifocal transitional cell carcinoma of the bladder no greater than 5 cm, with evidence of muscle invasion documented by transurethral resection of the bladder (TURB), with no residual visible or palpable tumor mass at the end of TURB Stage II or III (T2-T3, N0, M0)
• No squamous cell or adenocarcinoma
• No evidence of pelvic lymph node involvement by CT scan or MRI
• No evidence of hydronephrosis
• No evidence of distant metastases
• No disease in the prostatic urethra

--Prior/Concurrent Therapy--

• Biologic therapy: Prior immunotherapy for superficial disease allowed; No concurrent growth factors
• Chemotherapy: No prior systemic chemotherapy; Prior intravesical chemotherapy or intravesical BCG allowed
• Endocrine therapy: Not specified
• Radiotherapy: No prior pelvic radiotherapy
• Surgery: No prior surgery for bladder cancer except transurethral resection of the bladder

--Patient Characteristics--

• Age: Under 76
• Performance status: WHO 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 11 g/dL
• Hepatic: Not specified
• Renal: See Disease Characteristics; Creatinine clearance greater than 50 mL/min
• Cardiovascular: No progressive ischemic cardiopathy
• Other: No reduced bladder capacity; No prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix treated by hysterectomy