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

Eastern Cooperative Oncology Group, American College of Surgeons, SWOG Cancer Research Network, NCIC Clinical Trials Group

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.

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.

DISEASE CHARACTERISTICS: Single renal T1-2 tumor suspicious for adenocarcinoma that meets the following requirements: Solitary tumor on CT scan Maximum diameter 5 cm Located such that negative resection margins are assured N0, M0, i.e., no nodal involvement or distant metastases No invasion of renal pelvis, calices, or perirenal fat as determined by CT scan or intravenous urography Normal contralateral kidney present No von Hippel-Lindau disease PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy except adequately treated nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

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