S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
NCT ID: NCT01224665
Last Updated: 2024-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
658 participants
INTERVENTIONAL
2011-11-25
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
therapeutic conventional surgery therapeutic standard lymphadenectomy
therapeutic conventional surgery
Patients undergo radical cystectomy
therapeutic standard lymphadenectomy
Patients undergo standard pelvic lymphadenectomy.
Arm II
therapeutic conventional surgery therapeutic extended lymphadenectomy
therapeutic conventional surgery
Patients undergo radical cystectomy
therapeutic extended lymphadenectomy
Patients undergo extended pelvic lymphadenectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
therapeutic conventional surgery
Patients undergo radical cystectomy
therapeutic standard lymphadenectomy
Patients undergo standard pelvic lymphadenectomy.
therapeutic extended lymphadenectomy
Patients undergo extended pelvic lymphadenectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Seth P. Lerner, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
St 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lerner SP, Tangen C, Svatek RS, Daneshmand S, Pohar KS, Skinner E, Schuckman A, Sagalowsky AI, Smith ND, Kamat AM, Kassouf W, Plets M, Bangs R, Koppie TM, Alva A, La Rosa FG, Pal SK, Kibel AS, Canter DJ, Thompson IM Jr; SWOG S1011 Trial Investigators. Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer. N Engl J Med. 2024 Oct 3;391(13):1206-1216. doi: 10.1056/NEJMoa2401497.
Kamat AM, Hahn NM, Efstathiou JA, Lerner SP, Malmstrom PU, Choi W, Guo CC, Lotan Y, Kassouf W. Bladder cancer. Lancet. 2016 Dec 3;388(10061):2796-2810. doi: 10.1016/S0140-6736(16)30512-8. Epub 2016 Jun 23.
Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hubler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SWOG-S1011
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCI-2011-02604
Identifier Type: REGISTRY
Identifier Source: secondary_id
S1011
Identifier Type: -
Identifier Source: org_study_id