S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: therapeutic conventional surgery Type: Procedure
Name: therapeutic lymphadenectomy Type: Procedure
Overall Status
Recruiting
Summary
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.

PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Status: Recruiting
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente - 323-865-0451
University of California Davis Cancer Center
Sacramento, California, United States
Status: Recruiting
Contact: Clinical Trials Office - University of California Davis Cancer - 916-734-3089
Stanford Cancer Center
Stanford, California, United States
Status: Recruiting
Contact: Clinical Trials Office - Stanford Cancer Center - 650-498-7061 - cctoffice@stanford.edu
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - University of Chicago Cancer Research - 773-834-7424
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center - 708-226-4357
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Robert L. Grubb, III - 314-747-7222
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Bernard H. Bochner - 212-639-8895
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Status: Recruiting
Contact: Jonathan W. Friedberg - 585-275-5345
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Ohio State University Cancer Clinical Trial Matching Service - 866-627-7616 - Jamesline@osumc.edu
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea - 503-494-1080 - trials@ohsu.edu
Parkland Memorial Hospital
Dallas, Texas, United States
Status: Recruiting
Contact: Arthur I. Sagalowsky, MD - 214-648-3976
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Status: Recruiting
Contact: Arthur Sagalowsky, MD - 214-648-3976 - arthur.sagalowsky@utsouthwestern.edu
Baylor University Medical Center - Houston
Houston, Texas, United States
Status: Recruiting
Contact: Seth P. Lerner, MD - 713-798-6841
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U - 713-792-3245
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Seth P. Lerner, MD - 713-798-6841
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Robert S. Svatek - 210-567-4777
Start Date
August 2011
Sponsors
Southwest Oncology Group
Source
Southwest Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page