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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00743236
Collaborator
National Cancer Institute (NCI) (NIH)
1
Enrollment
8
Locations
2
Arms
10
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cold ischemia procedure
  • Procedure: warm ischemia procedure
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Creatinine clearance at 1 year [at 1 year after nephrectomy.]

  2. Estimated glomerular filtration rate (GFR) [at 1 year after nephrectomy.]

Secondary Outcome Measures

  1. Evidence of local or metastatic recurrence [at 1 year after nephrectomy.]

  2. Cancer-specific survival [at 1 year after nephrectomy.]

  3. Overall survival [at 1 year after nephrectomy.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00743236
Other Study ID Numbers:
  • CCCWFU-89108
  • CDR0000612519
  • NCI-2009-01120
First Posted:
Aug 28, 2008
Last Update Posted:
Apr 6, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
perioperative/postoperative complications
urinary complications
long-term effects secondary to cancer therapy in adults
stage I renal cell cancer
Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Ischemia
Postoperative Complications

Study Results

No Results Posted as of Apr 6, 2017