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
Principal Investigator
William Shipley, MD
Status
Terminated
Date Opened To Accrual
October 26 2009
Date Closed to Accrual
December 20 2017
Date of Study Termination
August 15 2023
Disease Site
Genitourinary [GU]
Bladder
Phase
II
Developmental Therapeutics
No
Primary Objective
To evaluate the rate of freedom from radical cystectomy at 3 years.
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Patient Population
- Operable patients with non-muscle invading tumors and with at least one being a high grade Stage T1 urothelial carcinoma for whom radical cystectomy is being considered as the next conventional step in therapy by standard urologic guidelines
- AJCC Stages T1, NX or N0, M0, only transitional cell histology
- Restaged by a urologist in the participating institution with an aggressive, visibly complete TURBT with muscularis propria in the specimen but with no evidence of its invasion by tumor
- Failed standard treatment with, or is medically ineligible for, intravesical biological therapy or chemotherapy
- No evidence of prostatic stromal invasion by tumor
Target Accrual
37
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.