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
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Disease-free progression
No
Seth P. Lerner, MD
Principal Investigator
Baylor College of Medicine
Unspecified
CDR0000686574
NCT01224665
August 2011
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | Houston, Texas 77030 |