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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00743236
First received: August 27, 2008
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Kidney Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Perioperative/Postoperative Complications
Urinary Complications
Procedure: cold ischemia procedure
Procedure: warm ischemia procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Creatinine clearance at 1 year [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (GFR) at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of local or metastatic recurrence [ Designated as safety issue: No ]
  • Cancer-specific survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: August 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743236

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

Additional Information:
No publications provided

Responsible Party: Regulatory Affairs Associate, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00743236     History of Changes
Other Study ID Numbers: CCCWFU-89108, CDR0000612519, NCI-2009-01120
Study First Received: August 27, 2008
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
perioperative/postoperative complications
urinary complications
long-term effects secondary to cancer therapy in adults
stage I renal cell cancer

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

ClinicalTrials.gov processed this record on July 23, 2014