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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: Primary - To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy. Secondary - To compare overall survival (OS) of patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. - To evaluate operative time; whether or not nerve sparing was performed, intraoperative, peri-operative and 90-day morbidity and mortality; length of hospital stay; histology (pure urothelial versus mixed); lymph node counts and lymph node density; adjuvant chemotherapy received; and local and retroperitoneal soft tissue recurrence in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. - To collect peripheral blood and two paraffin-embedded blocks of the primary tumor for translational medicine studies, including circulating tumor cells (CTCs) and markers of epithelial and mesenchymal transition, and correlate these findings with pathologic T stage and node metastasis as well as DFS and OS. OUTLINE: This is a multicenter study. Patients are stratified according to prior neoadjuvant therapy (yes vs no), clinical stage (T2 vs T3 vs T4a), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radical cystectomy and standard pelvic lymphadenectomy. - Arm II: Patients undergo radical cystectomy and extended pelvic lymphadenectomy. Blood and tumor specimens may be collected periodically for translational studies. After completion of study therapy, patients are followed up periodically for 6 years.

Who is eligible to participate?

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

Last updated:

6/23/2014

NCT ID:

NCT01224665

IRB Number:

13-003850