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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 3

Conditions: Kidney Cancer

Treatments: Procedure: conventional surgery

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00002473

EORTC-30904

CAN-NCIC-RE1

E-30904

ACOSOG-30904

SWOG-EORTC-30904

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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