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

June 11, 2013 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H95 3Y7
        • McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
American College of Surgeons

Investigators

  • Study Chair: Leonard G. Gomella, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1992

Primary Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30904
  • ACOSOG-30904
  • CAN-NCIC-RE1
  • E-30904
  • SWOG-EORTC-30904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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