Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With 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