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

Wake Forest University Health Sciences1 enrolled

Overview

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 * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Kidney Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (8)

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States