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

Primary Purpose

Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cold ischemia procedure
warm ischemia procedure
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring perioperative/postoperative complications, urinary complications, long-term effects secondary to cancer therapy in adults, stage I renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • George Washington University Medical Center
  • University of Chicago Cancer Research Center
  • NYU Cancer Institute at New York University Medical Center
  • Wake Forest University Comprehensive Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Huntsman Cancer Institute at University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients undergo warm ischemia followed by partial nephrectomy.

Patients undergo cold ischemia followed by partial nephrectomy.

Outcomes

Primary Outcome Measures

Creatinine clearance at 1 year
Estimated glomerular filtration rate (GFR)

Secondary Outcome Measures

Evidence of local or metastatic recurrence
Cancer-specific survival
Overall survival

Full Information

First Posted
August 27, 2008
Last Updated
April 4, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00743236
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo warm ischemia followed by partial nephrectomy.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo cold ischemia followed by partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
cold ischemia procedure
Intervention Description
Cold ischemia followed by partial nephrectomy
Intervention Type
Procedure
Intervention Name(s)
warm ischemia procedure
Intervention Description
Warm ischemia followed by partial nephrectomy
Primary Outcome Measure Information:
Title
Creatinine clearance at 1 year
Time Frame
at 1 year after nephrectomy.
Title
Estimated glomerular filtration rate (GFR)
Time Frame
at 1 year after nephrectomy.
Secondary Outcome Measure Information:
Title
Evidence of local or metastatic recurrence
Time Frame
at 1 year after nephrectomy.
Title
Cancer-specific survival
Time Frame
at 1 year after nephrectomy.
Title
Overall survival
Time Frame
at 1 year after nephrectomy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A. Pettus, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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