Status:
COMPLETED
Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Eligibility:
All Genders
18-120 years
Phase:
NA
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 m...
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 kid...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00743236
Start Date
August 1 2008
End Date
June 1 2009
Last Update
April 6 2017
Active Locations (8)
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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 D.C., 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