Spots Global Cancer Trial Database for S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
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Trial Identification
Brief Title: S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
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
Study ID: NCT01224665
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Portland Veterans Administration Medical Center, Portland, Oregon, 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
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
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
QEII Health Sciences Centre/Capital District Health Authority, Halifax, Nova Scotia, Canada
London Regional Cancer Program, London, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, Canada
Contact Details
Name: Seth P. Lerner, MD
Affiliation: Baylor College of Medicine
Role: PRINCIPAL_INVESTIGATOR
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