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

Not Applicable

Completed

• Conditions: Urinary Complications; Kidney Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Perioperative/Postoperative Complications
• Interventions: Procedure: warm ischemia procedure; Procedure: cold ischemia procedure

• Registration Number: NCT00743236
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	warm ischemia procedure	Patients undergo warm ischemia followed by partial nephrectomy.
Arm II	cold ischemia procedure	Patients undergo cold ischemia followed by partial nephrectomy.

Primary Outcome Measures

Name	Time	Method
Creatinine clearance at 1 year	at 1 year after nephrectomy.
Estimated glomerular filtration rate (GFR)	at 1 year after nephrectomy.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, 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

NYU Cancer Institute at New York University Medical Center; 🇺🇸 New York, New York, United States

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States