A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma

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.