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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000612519 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2009-01120 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo warm ischemia followed by partial nephrectomy. |
|
| Arm II | Experimental | Patients undergo cold ischemia followed by partial nephrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cold ischemia procedure | Procedure | Cold ischemia followed by partial nephrectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine clearance at 1 year | at 1 year after nephrectomy. | |
| Estimated glomerular filtration rate (GFR) | at 1 year after nephrectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of local or metastatic recurrence | at 1 year after nephrectomy. | |
| Cancer-specific survival | at 1 year after nephrectomy. | |
| Overall survival |
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DISEASE CHARACTERISTICS:
Diagnosis of solitary renal cortical tumor
Candidate for open partial nephrectomy
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A. Pettus, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | 92868 | United States | ||
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| warm ischemia procedure |
| Procedure |
Warm ischemia followed by partial nephrectomy |
|
| at 1 year after nephrectomy. |
| George Washington University Medical Center |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D011183 | Postoperative Complications |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D050377 | Cold Ischemia |
| D052096 | Warm Ischemia |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D014021 | Tissue Preservation |
| D011309 | Preservation, Biological |
| D008919 | Investigative Techniques |
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