Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00743236
Other study ID # CCCWFU-89108
Secondary ID CDR0000612519NCI
Status Completed
Phase N/A
First received August 27, 2008
Last updated April 4, 2017
Start date August 2008
Est. completion date June 2009

Study information

Verified date April 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
cold ischemia procedure
Cold ischemia followed by partial nephrectomy
warm ischemia procedure
Warm ischemia followed by partial nephrectomy

Locations

Country Name City State
United States University of Chicago Cancer Research Center Chicago Illinois
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas
United States NYU Cancer Institute at New York University Medical Center New York New York
United States Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah
United States George Washington University Medical Center Washington District of Columbia
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Creatinine clearance at 1 year at 1 year after nephrectomy.
Primary Estimated glomerular filtration rate (GFR) at 1 year after nephrectomy.
Secondary Evidence of local or metastatic recurrence at 1 year after nephrectomy.
Secondary Cancer-specific survival at 1 year after nephrectomy.
Secondary Overall survival at 1 year after nephrectomy.
See also
  Status Clinical Trial Phase
Completed NCT00541008 - Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01048892 - Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features Phase 1
Withdrawn NCT00769990 - Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases Phase 1/Phase 2
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Recruiting NCT00301990 - Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00467077 - Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer Phase 2
Completed NCT00098943 - NGR-TNF in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT00899860 - Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer N/A
Terminated NCT00089102 - Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer Phase 2
Completed NCT00021021 - RPI.4610 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00006968 - Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer Phase 1/Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1