Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function

Conditions
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Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications, Urinary Complications

Intervention / Treatment
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* Procedure: cold ischemia procedure
* Procedure: warm ischemia procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo warm ischemia followed by partial nephrectomy. | Procedure: warm ischemia procedure<br>* Warm ischemia followed by partial nephrectomy<br>|
| Experimental: Arm II<br>Patients undergo cold ischemia followed by partial nephrectomy. | Procedure: cold ischemia procedure<br>* Cold ischemia followed by partial nephrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance at 1 year |  | at 1 year after nephrectomy. | 
| Estimated glomerular filtration rate (GFR) |  | at 1 year after nephrectomy. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | at 1 year after nephrectomy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative/postoperative complications, urinary complications, long-term effects secondary to cancer therapy in adults, stage I renal cell cancer