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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008

Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00743236
  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
Cancer-Related Problem/Condition
Kidney Cancer
Procedure: cold ischemia procedure
Procedure: warm ischemia procedure
Phase III

MedlinePlus related topics:   Cancer    Kidney Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind
Official Title:   A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:   176
Study Start Date:   August 2008
Estimated Primary Completion Date:   August 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Experimental
Patients undergo warm ischemia followed by partial nephrectomy.
Procedure: warm ischemia procedure
Warm ischemia followed by partial nephrectomy
Arm II: Experimental
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

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     Recruiting
      Orange, California, United States, 92868
      Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent     877-UC-STUDY     ucstudy@uci.edu    
United States, District of Columbia
George Washington University Medical Center     Recruiting
      Washington, District of Columbia, United States, 20037
      Contact: Clinical Trials Office - George Washington University Medical     202-741-2981        
United States, Illinois
University of Chicago Cancer Research Center     Recruiting
      Chicago, Illinois, United States, 60637-1470
      Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, New York
NYU Cancer Institute at New York University Medical Center     Recruiting
      New York, New York, United States, 10016
      Contact: William Huang, MD     646-744-1503        
United States, North Carolina
Wake Forest University Comprehensive Cancer Center     Recruiting
      Winston-Salem, North Carolina, United States, 27157-1096
      Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center     Recruiting
      Columbus, Ohio, United States, 43210-1240
      Contact: Clinical Trials Office - OSU Comprehensive Cancer Center     614-293-4976     osu@emergingmed.com    
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas     Recruiting
      Dallas, Texas, United States, 75390
      Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
United States, Utah
Huntsman Cancer Institute at University of Utah     Recruiting
      Salt Lake City, Utah, United States, 84112
      Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi     801-581-4477     clinical.trials@hci.utah.edu    

Sponsors and Collaborators
Wake Forest University
National Cancer Institute (NCI)

Investigators
Study Chair:     Joseph A. Pettus, MD     Wake Forest University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Wake Forest University Comprehensive Cancer Center ( Regulatory Protocol Associate )
Study ID Numbers:   CDR0000612519, CCCWFU-89108
First Received:   August 27, 2008
Last Updated:   October 17, 2008
ClinicalTrials.gov Identifier:   NCT00743236
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
perioperative/postoperative complications  
urinary complications  
long-term effects secondary to cancer therapy in adults  
stage I renal cell cancer  

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Ischemia
Urologic Neoplasms
Kidney cancer
Carcinoma
Postoperative Complications
Urologic Diseases
Kidney Neoplasms
Neoplasm Metastasis
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on December 02, 2008




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