Trials / Completed
CompletedNCT00002473
Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | conventional surgery |
Timeline
- Start date
- 1992-03-01
- Primary completion
- 2011-02-01
- First posted
- 2003-01-27
- Last updated
- 2013-06-12
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00002473. Inclusion in this directory is not an endorsement.