RTOG-0712

A Phase II Randomized Study for Patients with Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery and Concomitant Chemoradiation by Either BID Irradiation Plus 5-Fluorouracil and Cisplatin or QD Irradiation Plus Gemcitabine Followed by Selective Bladder Preservation and Gemcitabine/Cisplatin Adjuvant Chemotherapy

Principal Investigator

John J. Coen

Status

Disease Site

Genitourinary [GU] Bladder

Phase

II

Developmental Therapeutics

No

Primary Objective

To estimate the rate of distant metastasis at 3 years of two induction chemoradiotherapy regimens including 5-Fluorouracil, cisplatin, and BID irradiation (FCI) or gemcitabine and QD irradiation (GI). Induction chemoradiotherapy will be followed by radical cystectomy if the initial tumor response is incomplete or by consolidation chemoradiotherapy if the tumor has cleared, and both will be followed by adjuvant chemotherapy.

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 – AJCC Stages T2-T4a, NX or N0, M0 – No histologic evidence of tumor invasion into the stroma of the prostate – No tumor-related hydronephrosis

Target Accrual

64