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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01224665
• Other study ID #: S1011
• Secondary ID: SWOG-S1011NCI-20
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2011
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: SWOG Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 658
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• therapeutic conventional surgery
Patients undergo radical cystectomy
• therapeutic standard lymphadenectomy
Patients undergo standard pelvic lymphadenectomy.
• therapeutic extended lymphadenectomy
Patients undergo extended pelvic lymphadenectomy

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre/Capital District Health Authority	Halifax	Nova Scotia
Canada	London Regional Cancer Program	London	Ontario
Canada	McGill University Department of Oncology	Montreal	Quebec
Canada	The Research Institute of the McGill University Health Centre (MUHC)	Montreal	Quebec
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario
Canada	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia
United States	University of Colorado Cancer Center - Anschutz Cancer Pavilion	Aurora	Colorado
United States	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas
United States	Baylor Saint Luke's Medical Center	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Yale University	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Stanford Cancer Institute	Palo Alto	California
United States	Oregon Health and Science University	Portland	Oregon
United States	Portland Veterans Administration Medical Center	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Audie L Murphy Veterans Affairs Hospital	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	UCSF Medical Center-Mission Bay	San Francisco	California
United States	UCSF Medical Center-Mount Zion	San Francisco	California
United States	Louisiana State University Health Sciences Center Shreveport	Shreveport	Louisiana
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
SWOG Cancer Research Network	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		Up to 6 years from date of Step 2 Registration
Secondary	Overall survival		Up to 6 years from date of Step 2 Registration
Secondary	Morbidity		Up to 6 years from date of Step 2 Registration