A Phase III Surgical Trial to Evaluate The Benefit Of A Standard Versus An Extended Pelvic Lymphadenectomy Performed At Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer

Pts must have histologically-proven T2, T3 or T4a bladder ca requiring radical cystectomy. Pt must not have clinical stage consistent with low-risk of node mets (CIS only, T1) nor T4b (fixed lesion). Pts with predominantly small cell, squamous cell, or adenocarcinoma histologies are not eligible. There must be plans for cystectomy and LND w/in 28 days of registration by study-specific credentialed surgeon. Laparoscopic surgery is not allowed. No prior partial cystectomy for invasive bladder ca. Pts must not have received any prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g. aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised. Prior neoadj chemo ok if completed w/in 70 days prior to planned cystectomy and pt recovered from associated toxicities. No prior pelvic irradiation. No evidence of visceral or nodal mets proximal to common iliac bifurcation on CXR or CT of abd and abd/pelvic CT or MRI w/in 56 days prior to reg. Bili, SGOT, SGPT, alk phos w/in IULN w/in 28 days prior to reg. These lab values may be greater than IULN if met dx excluded w/appropriate imaging. Prestudy physical exam & med hx w/in 28 days prior to reg. Pt must be offered specimen banking. Pt must have Zubrod PS of 0-2 and be medically suitable for cystectomy. Pt must not be pregnant or nursing at the time of radical cystectomy and women must have agreed to use effective contraceptive method. No other prior malignancy as outlined in 5.3e.