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About
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.
Full description
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.
Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
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Inclusion and exclusion 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
Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed
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:
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Hepatic:
Renal:
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PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Data sourced from clinicaltrials.gov
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