Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00002473|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Procedure: conventional surgery||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||February 2011|
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): 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||Emory University|
|Study Chair:||Leonard G. Gomella, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Study Chair:||Eila C. Skinner, MD||University of Southern California|
|Study Chair:||Laurence H. Klotz, MD||Toronto Sunnybrook Regional Cancer Centre|