Kidney Cancer Clinical Trial
Official title:
A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
Verified date | April 2017 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
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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