Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00743236

Purpose

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	Intervention	Phase
Kidney Cancer Long-term Effects Secondary to Cancer Therapy in Adults Perioperative/Postoperative Complications Urinary Complications	Procedure: cold ischemia procedure Procedure: warm ischemia procedure	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind
Official Title:	A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Creatinine clearance at 1 year [ Designated as safety issue: No ]
Estimated glomerular filtration rate (GFR) at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evidence of local or metastatic recurrence [ Designated as safety issue: No ]
Cancer-specific survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	176
Study Start Date:	August 2008
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients undergo warm ischemia followed by partial nephrectomy.	Procedure: warm ischemia procedure Warm ischemia followed by partial nephrectomy
Arm II: Experimental Patients undergo cold ischemia followed by partial nephrectomy.	Procedure: cold ischemia procedure Cold ischemia followed by partial nephrectomy

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743236

Locations

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

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Joseph A. Pettus, MD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wake Forest University Comprehensive Cancer Center ( Regulatory Affairs Associate )
Study ID Numbers:	CDR0000612519, CCCWFU-89108
Study First Received:	August 27, 2008
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00743236 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

perioperative/postoperative complications
urinary complications
long-term effects secondary to cancer therapy in adults
stage I renal cell cancer

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Urogenital Neoplasms
Ischemia
Urologic Neoplasms
Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Urologic Diseases
Postoperative Complications
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasm Metastasis
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009