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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002473
First Posted: January 27, 2003
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eastern Cooperative Oncology Group
American College of Surgeons
Southwest Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  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:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Hospital, Gasthuisberg
Study Chair: Thomas Keane, MD Emory University
Study Chair: Leonard G. Gomella, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Chair: Eila C. Skinner, MD University of Southern California
Study Chair: Laurence H. Klotz, MD Toronto Sunnybrook Regional Cancer Centre
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002473     History of Changes
Other Study ID Numbers: EORTC-30904
ACOSOG-30904
CAN-NCIC-RE1
E-30904
SWOG-EORTC-30904
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I renal cell cancer
stage II renal cell cancer

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