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

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
American College of Surgeons
Southwest Oncology Group
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002473
First received: November 1, 1999
Last updated: February 10, 2011
Last verified: July 2002
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
 Procedure: conventional surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 1992
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002473

Locations
Canada, Ontario
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H95 3Y7
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Eastern Cooperative Oncology Group
American College of Surgeons
Southwest Oncology Group
NCIC Clinical Trials Group
Investigators
Study Chair: Hein van Poppel, MD, PhD U.Z. Gasthuisberg
Study Chair: Thomas Keane, MD Winship Cancer Institute of Emory University
Study Chair: Leonard G. Gomella, MD Kimmel Cancer Center (KCC)
Study Chair: Eila C. Skinner, MD USC/Norris Comprehensive Cancer Center
Study Chair: Laurence H. Klotz, MD Edmond Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00002473     History of Changes
Other Study ID Numbers: CDR0000076837, EORTC-30904, ACOSOG-30904, CAN-NCIC-RE1, E-30904, SWOG-EORTC-30904
Study First Received: November 1, 1999
Last Updated: February 10, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I renal cell cancer
stage II renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013