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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Arm I

Patients undergo warm ischemia followed by partial nephrectomy.

Group Type EXPERIMENTAL

warm ischemia procedure

Intervention Type PROCEDURE

Warm ischemia followed by partial nephrectomy

Arm II

Patients undergo cold ischemia followed by partial nephrectomy.

Group Type EXPERIMENTAL

cold ischemia procedure

Intervention Type PROCEDURE

Cold ischemia followed by partial nephrectomy

Interventions

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cold ischemia procedure

Cold ischemia followed by partial nephrectomy

Intervention Type PROCEDURE

warm ischemia procedure

Warm ischemia followed by partial nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No