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

Kidney Cancer Clinical Trial

Official title:

A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002473
• Other study ID #: EORTC-30904
• Secondary ID: EORTC-30904ACOSO
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 11, 2013
• Start date: March 1992

Study information

• Verified date: June 2013
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
Canada	Sunnybrook and Women's College Health Sciences Centre	North York	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	American College of Surgeons, Canadian Cancer Trials Group, Eastern Cooperative Oncology Group, Southwest Oncology Group

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, Colombel M, Klotz L, Skinner E, Keane T, Marreaud S, Collette S, Sylvester R. A prospective, randomised EORTC intergroup phase 3 study comparing the oncologic outcome of elective nephro — View Citation

Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, Marechal JM, Klotz L, Skinner E, Keane T, Claessens I, Sylvester R; European Organization for Research and Treatment of Cancer (EORTC); National Cancer Institute of Canada Clinical Tria — View Citation