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A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging

Primary To evaluate the rate of freedom from radical cystectomy at 3 years. Secondary To evaluate the rate of freedom from radical cystectomy at 5 years. To evaluate the rate of freedom from the development of distant disease progression at 3 and 5 years. Rate of freedom from progression of bladder tumor to stage T2 or greater at 3 and 5 years. To evaluate the disease-specific survival and overall survival. To evaluate the incidence of acute and late pelvic toxicity To evaluate the efficacy of this treatment approach in preventing the recurrence of any local bladder tumor. To evaluate the potential value of tumor histopathology plus molecular genetic, DNA content, and urine proteomics parameters as possible significant prognostic factors for tumor control with this treatment approach. To collect American Urological Association (AUA) symptom scores at baseline and at 3 years.

Phase

II

Recruitment Status

Past Studies