Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
|ClinicalTrials.gov Identifier: NCT00743236|
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : April 6, 2017
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 or disease||Intervention/treatment|
|Kidney Cancer Long-term Effects Secondary to Cancer Therapy in Adults Perioperative/Postoperative Complications Urinary Complications||Procedure: cold ischemia procedure Procedure: warm ischemia procedure|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function|
|Study Start Date :||August 2008|
|Primary Completion Date :||June 2009|
|Study Completion Date :||June 2009|
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
- Creatinine clearance at 1 year [ Time Frame: at 1 year after nephrectomy. ]
- Estimated glomerular filtration rate (GFR) [ Time Frame: at 1 year after nephrectomy. ]
- Evidence of local or metastatic recurrence [ Time Frame: at 1 year after nephrectomy. ]
- Cancer-specific survival [ Time Frame: at 1 year after nephrectomy. ]
- Overall survival [ Time Frame: at 1 year after nephrectomy. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743236
|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|
|Study Chair:||Joseph A. Pettus, MD||Wake Forest University Health Sciences|