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 Zietman, MD
Status
Terminated
Date Closed to Accrual
January 11 2008
Date of Study Termination
May 04 2018
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.