Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer

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

Summary

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 chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.

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

Details

• Lead Sponsor: Medical Research Council
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of transitional cell carcinoma of the bladder

• Stage T1 Nx M0, grade 3 disease

• No muscle invasion at base of tumor

• Diagnosis of this stage made within the past 6 months

• Earlier diagnosis of tumors with lower stage or grade allowed

• No history of higher stage urothelial tumors

• Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed

• No widespread CIS causing severe symptoms

• Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required

• Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No more than 1 prior adjuvant treatment with intravesical BCG

Chemotherapy:

• No more than 1 prior adjuvant treatment with intravesical chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

• Diathermic removal of associated small papillary growths allowed