Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

658

Study ID:

NCT01224665

Recruitment Status:

Active, not recruiting

Sponsor:

Southwest Oncology Group

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There are 31 Locations for this study

See Locations Near You

Los Angeles County-USC Medical Center
Los Angeles California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Stanford Cancer Institute
Palo Alto California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
UCSF Medical Center-Mount Zion
San Francisco California, 94115, United States
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Yale University
New Haven Connecticut, 06520, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport Louisiana, 71103, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Portland Veterans Administration Medical Center
Portland Oregon, 97239, United States
Parkland Memorial Hospital
Dallas Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
Baylor Saint Luke's Medical Center
Houston Texas, 77030, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
Audie L Murphy Veterans Affairs Hospital
San Antonio Texas, 78209, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
BCCA-Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
QEII Health Sciences Centre/Capital District Health Authority
Halifax Nova Scotia, B3H 1, Canada
London Regional Cancer Program
London Ontario, N6A 4, Canada
University Health Network-Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
McGill University Department of Oncology
Montreal Quebec, H2W 1, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal Quebec, H3H 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

658

Study ID:

NCT01224665

Recruitment Status:

Active, not recruiting

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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