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| Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00743236 |
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 |
|
Cancer-Related Problem/Condition Kidney Cancer |
Procedure: cold ischemia procedure Procedure: warm ischemia procedure |
Phase III |
| MedlinePlus related topics: | Cancer Kidney Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind |
| Official Title: | A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function |
| Estimated Enrollment: | 176 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Arm I: Experimental
Patients undergo warm ischemia followed by partial nephrectomy.
|
Procedure: warm ischemia procedure
Warm ischemia followed by partial nephrectomy
|
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Arm II: Experimental
Patients undergo cold ischemia followed by partial nephrectomy.
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Procedure: cold ischemia procedure
Cold ischemia followed by partial nephrectomy
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
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 |
DISEASE CHARACTERISTICS:
Diagnosis of solitary renal cortical tumor
Candidate for open partial nephrectomy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |||||
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Recruiting | ||||
| Orange, California, United States, 92868 | |||||
| Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-UC-STUDY ucstudy@uci.edu | |||||
| United States, District of Columbia | |||||
| George Washington University Medical Center | Recruiting | ||||
| Washington, District of Columbia, United States, 20037 | |||||
| Contact: Clinical Trials Office - George Washington University Medical 202-741-2981 | |||||
| United States, Illinois | |||||
| University of Chicago Cancer Research Center | Recruiting | ||||
| Chicago, Illinois, United States, 60637-1470 | |||||
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |||||
| United States, New York | |||||
| NYU Cancer Institute at New York University Medical Center | Recruiting | ||||
| New York, New York, United States, 10016 | |||||
| Contact: William Huang, MD 646-744-1503 | |||||
| United States, North Carolina | |||||
| Wake Forest University Comprehensive Cancer Center | Recruiting | ||||
| Winston-Salem, North Carolina, United States, 27157-1096 | |||||
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |||||
| United States, Ohio | |||||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting | ||||
| Columbus, Ohio, United States, 43210-1240 | |||||
| Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com | |||||
| United States, Texas | |||||
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting | ||||
| Dallas, Texas, United States, 75390 | |||||
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |||||
| United States, Utah | |||||
| Huntsman Cancer Institute at University of Utah | Recruiting | ||||
| Salt Lake City, Utah, United States, 84112 | |||||
| Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi 801-581-4477 clinical.trials@hci.utah.edu | |||||
| Wake Forest University |
| National Cancer Institute (NCI) |
| Study Chair: | Joseph A. Pettus, MD | Wake Forest University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Responsible Party: | Wake Forest University Comprehensive Cancer Center ( Regulatory Protocol Associate ) |
| Study ID Numbers: | CDR0000612519, CCCWFU-89108 |
| First Received: | August 27, 2008 |
| Last Updated: | October 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00743236 |
| Health Authority: | Unspecified |
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