A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Hein van Poppel, MD, PhD
United States: Federal Government