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 Coen, MD
Status
Terminated
Date of Study Termination
May 20 2022
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.