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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed urothelial carcinoma of the bladder

- Stage T2, T3, or T4a disease

- No clinical stage consistent with a low-risk of node metastasis (CIS only,
T1)

- No T4b disease (fixed lesion)

- Disease that requires primary radical cystectomy and lymph node dissection for
definitive treatment

- No laparoscopic surgery

- Predominant urothelial carcinoma with any of the following elements allowed:

- Adenocarcinoma

- Squamous cell carcinoma

- Micropapillary or minor components of other rare phenotype

- No pure squamous cell carcinoma or adenocarcinoma

- No visceral or nodal metastatic disease proximal to the common iliac bifurcation by
2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of
the abdomen and pelvis

- No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or
above the bifurcation of the common iliac vessels in any of the extended template

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ALT and AST ≤ upper limit of normal (ULN)*

- Alkaline phosphatase ≤ ULN*

- Not pregnant or nursing

- Fertile patients must use an effective contraception

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in
complete remission for the past 5 years

- Medically suitable to undergo cystectomy, in the physician's opinion NOTE: *Levels
may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging,
bone scan, or biopsy.

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior partial cystectomy for invasive bladder cancer

- No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g.,
aorto-femoral/iliac bypass)

- Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed
and patient has recovered

- No prior pelvic irradiation