Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00002473
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
McGill University
🇨🇦Montreal, Quebec, Canada
Sunnybrook and Women's College Health Sciences Centre
🇨🇦North York, Ontario, Canada