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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743236
• Other study ID #: CCCWFU-89108
• Secondary ID: CDR0000612519NCI
• Status: Completed
• Phase: N/A
• First received: August 27, 2008
• Last updated: April 4, 2017
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Ischemia
• Kidney Cancer
• Kidney Neoplasms
• Long-term Effects Secondary to Cancer Therapy in Adults
• Perioperative/Postoperative Complications
• Postoperative Complications
• Urinary Complications

Intervention

Procedure:
• cold ischemia procedure
Cold ischemia followed by partial nephrectomy
• warm ischemia procedure
Warm ischemia followed by partial nephrectomy

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
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	NYU Cancer Institute at New York University Medical Center	New York	New York
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine clearance at 1 year		at 1 year after nephrectomy.
Primary	Estimated glomerular filtration rate (GFR)		at 1 year after nephrectomy.
Secondary	Evidence of local or metastatic recurrence		at 1 year after nephrectomy.
Secondary	Cancer-specific survival		at 1 year after nephrectomy.
Secondary	Overall survival		at 1 year after nephrectomy.