Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
This study has been completed.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00743236
First received: August 27, 2008
Last updated: June 4, 2013
Last verified: June 2013
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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 |
|---|---|---|
|
Kidney Cancer Long-term Effects Secondary to Cancer Therapy in Adults Perioperative/Postoperative Complications Urinary Complications |
Procedure: cold ischemia procedure Procedure: warm ischemia procedure |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
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 ]
| Enrollment: | 1 |
| Study Start Date: | August 2008 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo warm ischemia followed by partial nephrectomy.
|
Procedure: warm ischemia procedure
Warm ischemia followed by partial nephrectomy
|
|
Experimental: Arm II
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 | |
| Orange, California, United States, 92868 | |
| United States, District of Columbia | |
| George Washington University Medical Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Texas | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Study Chair: | Joseph A. Pettus, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Regulatory Affairs Associate, Wake Forest University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00743236 History of Changes |
| Other Study ID Numbers: | CCCWFU-89108, CDR0000612519, NCI-2009-01120 |
| Study First Received: | August 27, 2008 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
perioperative/postoperative complications urinary complications long-term effects secondary to cancer therapy in adults stage I renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Ischemia Postoperative Complications Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013