Clinical trial NCT00743236: Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Perioperative/Postoperative Complications
Urinary Complications
Keywords: perioperative/postoperative complications
urinary complications
long-term effects secondary to cancer therapy in adults
stage I renal cell cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Creatinine clearance at 1 year
timeFrame: at 1 year after nephrectomy.
measure: Estimated glomerular filtration rate (GFR)
timeFrame: at 1 year after nephrectomy.
Secondary outcomes:
measure: Evidence of local or metastatic recurrence
timeFrame: at 1 year after nephrectomy.
measure: Cancer-specific survival
timeFrame: at 1 year after nephrectomy.
measure: Overall survival
timeFrame: at 1 year after nephrectomy.
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
state: California
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: New York
country: United States
facility: NYU Cancer Institute at New York University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph A. Pettus, MD
role: STUDY_CHAIR
References: