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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002473

Enrollment

Unknown

Registered

2003-01-27

Start date

1992-03-31

Completion date

Unknown

Last updated

2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage I renal cell cancer, stage II renal cell cancer

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREconventional surgery

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026