RTOG-0233

A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabi

Principal Investigator

Anthony L. Zietman

Status

Disease Site

Genitourinary [GU] Bladder

Phase

II

Developmental Therapeutics

No

Primary Objective

To estimate the safety and tolerance of induction chemoradiotherapy including paclitaxel, cisplatin, and irradiation (TCI) or 5-Fluorouracil, cisplatin, and irradiation (FCI); chemoradiotherapy will be followed by radical cystectomy if the initial tumor response is incomplete or by consolidation chemoradiotherapy if the tumor has cleared. Four cycles of outpatient adjuvant gemcitabine-paclitaxel chemotherapy is then given.

Data Collection Notice:

Data for this trial is being collected via the NRG/RTOG Data Center.

Patient Population

Operable patients with muscularis propria invasion carcinoma of the bladder, all histologies

Target Accrual

96