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NCT Number: NCT00743236

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cold ischemia procedure

Procedure

Cold ischemia followed by partial nephrectomy

warm ischemia procedure

Procedure

Warm ischemia followed by partial nephrectomy

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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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