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CompletedNCT00743236Updated Apr 6, 2017

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

An interventional study of cold ischemia procedure and warm ischemia procedure in Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults and Perioperative/Postoperative Complications, sponsored by Wake Forest University Health Sciences. Completed at 8 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-04-06.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's enrollment of 1 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Arm I

    Patients undergo warm ischemia followed by partial nephrectomy.

    Procedure: warm ischemia procedure

  • Experimental
    Arm II

    Patients undergo cold ischemia followed by partial nephrectomy.

    Procedure: cold ischemia procedure

Interventions

  • Procedurecold ischemia procedure

    Cold ischemia followed by partial nephrectomy

  • Procedurewarm ischemia procedure

    Warm ischemia followed by partial nephrectomy

06

What researchers measure

Primary outcomes

  1. Creatinine clearance at 1 year

    Time frame: at 1 year after nephrectomy.

  2. Estimated glomerular filtration rate (GFR)

    Time frame: at 1 year after nephrectomy.

Secondary outcomes

  1. Evidence of local or metastatic recurrence

    Time frame: at 1 year after nephrectomy.

  2. Cancer-specific survival

    Time frame: at 1 year after nephrectomy.

  3. Overall survival

    Time frame: at 1 year after nephrectomy.

07

Study locations

8 sites
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    Orange, California 92868, United States
  • George Washington University Medical Center
    Washington, District of Columbia 20037, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • NYU Cancer Institute at New York University Medical Center
    New York, New York 10016, United States
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    Columbus, Ohio 43210-1240, United States
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    Dallas, Texas 75390, United States
  • Huntsman Cancer Institute at University of Utah
    Salt Lake City, Utah 84112, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00743236
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 28, 2008
Start date
Aug 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Apr 6, 2017

Study contacts

Joseph A. Pettus, MD
study chair · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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