S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01224665|
Recruitment Status : Recruiting
First Posted : October 20, 2010
Last Update Posted : April 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Procedure: therapeutic conventional surgery Procedure: therapeutic standard lymphadenectomy Procedure: therapeutic extended lymphadenectomy||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||620 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Active Comparator: Arm I
therapeutic conventional surgery therapeutic standard lymphadenectomy
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomyProcedure: therapeutic standard lymphadenectomy
Patients undergo standard pelvic lymphadenectomy.
Experimental: Arm II
therapeutic conventional surgery therapeutic extended lymphadenectomy
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomyProcedure: therapeutic extended lymphadenectomy
Patients undergo extended pelvic lymphadenectomy
- Disease-free survival [ Time Frame: Up to 6 years from date of Step 2 Registration ]
- Overall survival [ Time Frame: Up to 6 years from date of Step 2 Registration ]
- Morbidity [ Time Frame: Up to 6 years from date of Step 2 Registration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224665
|Contact: Jennifer I Scott||210-614-8808 ext email@example.com|
|Contact: Dana B Sparks, M.A.T.||210-614-8808 ext firstname.lastname@example.org|
Show 35 Study Locations
|Principal Investigator:||Seth P. Lerner, MD||Baylor College of Medicine|