RTOG-0926

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 U. Shipley

Status

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