Clinical Trials

Study closed to enrollment

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