Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
RATIONALE: Kidney-sparing surgery is a less invasive type of surgery for kidney cancer, and may have fewer side effects and improve recovery. It is unknown whether kidney-sparing surgery is more effective than kidney removal in treating kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to completely remove the kidney with kidney-sparing surgery in treating patients with resectable kidney cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma|
|Study Start Date:||March 1992|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- Compare time to recurrence and survival of patients with single, low stage, nonmetastatic, well localized, and well delineated renal cell cancer treated with partial vs radical resection.
- Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients.
- Study the relationship between tumor size, histologic grade, histologic type, and the extent of local control following partial resection.
- Determine which prognostic factors are important in selecting candidates for conservative surgery.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to undergo radical nephrectomy and limited lymphadenectomy (arm I) or conservative surgery (arm II).
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 1300 patients will be accrued for this study over 8 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002473
|Sunnybrook and Women's College Health Sciences Centre|
|North York, Ontario, Canada, M4N 3M5|
|Montreal, Quebec, Canada, H95 3Y7|
|Study Chair:||Hein van Poppel, MD, PhD||University Hospital, Gasthuisberg|
|Study Chair:||Thomas Keane, MD||Winship Cancer Institute of Emory University|
|Study Chair:||Leonard G. Gomella, MD||Kimmel Cancer Center (KCC)|
|Study Chair:||Eila C. Skinner, MD||University of Southern California|
|Study Chair:||Laurence H. Klotz, MD||Toronto Sunnybrook Regional Cancer Centre|