A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
18 Years
N/A
Both
Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications, Urinary Complications
Trial Information
A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Treatment
Outcome Measure:
Creatinine clearance at 1 year
Safety Issue:
No
Principal Investigator
Joseph A. Pettus, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CCCWFU-89108
NCT ID:
NCT00743236
Start Date:
August 2008
Completion Date:
Related Keywords:
- Kidney Cancer
- Long-term Effects Secondary to Cancer Therapy in Adults
- Perioperative/Postoperative Complications
- Urinary Complications
- perioperative/postoperative complications
- urinary complications
- long-term effects secondary to cancer therapy in adults
- stage I renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Ischemia
- Postoperative Complications
Name | Location |
|---|---|
| George Washington University Medical Center | Washington, District of Columbia 20037 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
