S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

Launched by SWOG CANCER RESEARCH NETWORK · Oct 19, 2010

Keywords

ClinConnect Summary

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 mi...

Gender

ALL

Eligibility 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