Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer

April 4, 2017 updated by: Wake Forest University Health Sciences

A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function

RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage I kidney cancer.

PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works compared with cold ischemia during surgery in treating patients with stage I kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the effect of warm ischemia during partial nephrectomy on long-term renal function in patients with solitary stage I renal cortical tumor and normal contralateral kidney.

Secondary

  • Determine to what degree the contralateral kidney compensates for the damage inflicted on the operated kidney during surgery.
  • Determine the 1-year disease-specific and overall survival of these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo warm ischemia followed by partial nephrectomy.
  • Arm II: Patients undergo cold ischemia followed by partial nephrectomy. Blood and urine samples are collected periodically after nephrectomy to assess renal function.

Patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

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

  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • New York
      • New York, New York, United States, 10016
        • NYU Cancer Institute at New York University Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at University of Utah

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

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of solitary renal cortical tumor

    • Tumor size ≤ 4 cm

  • Candidate for open partial nephrectomy

    • Expected ischemia time < 45 minutes
  • Normal renal function, defined as glomerular filtration rate (GFR) > 60 mL/min
  • No evidence of distant metastasis
  • No evidence of local invasion of adjacent structures, including the adrenal gland
  • No evidence of tumor extension into the renal venous system
  • No evidence of ureteral obstruction on MAG-3 renal scan
  • No family history of renal cancer

PATIENT CHARACTERISTICS:

  • ECOG performance status 0
  • Life expectancy > 5 years
  • No prior malignancy, except for non-melanomatous skin cancer

PRIOR CONCURRENT THERAPY:

  • 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
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients undergo warm ischemia followed by partial nephrectomy.
Procedure: warm ischemia procedure
Warm ischemia followed by partial nephrectomy
Experimental: Arm II
Patients undergo cold ischemia followed by partial nephrectomy.
Procedure: cold ischemia procedure
Cold ischemia followed by partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creatinine clearance at 1 year
Time Frame: at 1 year after nephrectomy.
at 1 year after nephrectomy.
Estimated glomerular filtration rate (GFR)
Time Frame: at 1 year after nephrectomy.
at 1 year after nephrectomy.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of local or metastatic recurrence
Time Frame: at 1 year after nephrectomy.
at 1 year after nephrectomy.
Cancer-specific survival
Time Frame: at 1 year after nephrectomy.
at 1 year after nephrectomy.
Overall survival
Time Frame: at 1 year after nephrectomy.
at 1 year after nephrectomy.

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Joseph A. Pettus, MD, Wake Forest University Health Sciences

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

August 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCWFU-89108
  • CDR0000612519 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-2009-01120 (Registry Identifier: CTRP (Clinical Trials Reporting System))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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