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 (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002473
First received: November 1, 1999
Last updated: June 11, 2013
Last verified: June 2013

November 1, 1999
June 11, 2013
March 1992
February 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002473 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Kidney Cancer
Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00002473
EORTC-30904, EORTC-30904, ACOSOG-30904, CAN-NCIC-RE1, E-30904, SWOG-EORTC-30904
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
  • Eastern Cooperative Oncology Group
  • American College of Surgeons
  • Southwest Oncology Group
  • NCIC Clinical Trials Group
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 University of Southern California
Study Chair: Laurence H. Klotz, MD Edmond Odette Cancer Centre at Sunnybrook
European Organisation for Research and Treatment of Cancer - EORTC
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP