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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00743236
Other study ID # CCCWFU-89108
Secondary ID CDR0000612519NCI
Status Completed
Phase N/A
First received August 27, 2008
Last updated April 4, 2017
Start date August 2008
Est. completion date June 2009

Study information

Verified date April 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
cold ischemia procedure
Cold ischemia followed by partial nephrectomy
warm ischemia procedure
Warm ischemia followed by partial nephrectomy

Locations

Country Name City State
United States University of Chicago Cancer Research Center Chicago Illinois
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas
United States NYU Cancer Institute at New York University Medical Center New York New York
United States Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah
United States George Washington University Medical Center Washington District of Columbia
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Creatinine clearance at 1 year at 1 year after nephrectomy.
Primary Estimated glomerular filtration rate (GFR) at 1 year after nephrectomy.
Secondary Evidence of local or metastatic recurrence at 1 year after nephrectomy.
Secondary Cancer-specific survival at 1 year after nephrectomy.
Secondary Overall survival at 1 year after nephrectomy.
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