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


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications, Urinary Complications

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Creatinine clearance at 1 year

Safety Issue:

No

Principal Investigator

Joseph A. Pettus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU-89108

NCT ID:

NCT00743236

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Perioperative/Postoperative Complications
  • Urinary Complications
  • perioperative/postoperative complications
  • urinary complications
  • long-term effects secondary to cancer therapy in adults
  • stage I renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Ischemia
  • Postoperative Complications

Name

Location

George Washington University Medical CenterWashington, District of Columbia  20037
University of Chicago Cancer Research CenterChicago, Illinois  60637
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240