• Adult Clinical Trials: Bladder

    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.

    • Pathologically (histologically or cytologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 6 weeks of registration.
    • Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are AJCC clinical stages T2-T4a, Nx or N0, M0 (Appendix IV) without hydronephrosis; patients who have involvement of the prostatic urethra with transitional cell cancer (TCC) that was visibly completely resected and no evidence of stromal invasion of the prostate remain eligible. (T2a, T2b, T3a, T3b "substages" are not usually able to be determined with clinical (TURBT) staging.
    • If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
    • Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible.
    • Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist. History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration.

    Treatment arms:
    Arm 1 (Induction and Consolidation):
    5-Fluorouracil (5-FU), Cisplatin
    Irradiation bid

    Arm 2 (Induction and Consolidation):
    Irradiation qd

    Re-examination of bladder:
    If tumor has completely disappeared, same chemotherapy and radiation + cisplatiin and gemcitabine
    If tumor has not completely disappeared, surgical removal of bladder + cisplatin and gemcitabine