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

NCT00743236 | Completed

• 3 other identifiers: CCCWFU-89108CDR0000612519NCI-2009-01120
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Creatinine clearance at 1 year

  at 1 year after nephrectomy.

• Estimated glomerular filtration rate (GFR)

  at 1 year after nephrectomy.

Secondary Outcomes (3)

• Evidence of local or metastatic recurrence

  at 1 year after nephrectomy.

• Cancer-specific survival

  at 1 year after nephrectomy.

• Overall survival

  at 1 year after nephrectomy.

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo warm ischemia followed by partial nephrectomy.

Procedure: warm ischemia procedure

Arm II

EXPERIMENTAL

Patients undergo cold ischemia followed by partial nephrectomy.

Procedure: cold ischemia procedure

Interventions

cold ischemia procedure PROCEDURE

Cold ischemia followed by partial nephrectomy

Arm II

warm ischemia procedure PROCEDURE

Warm ischemia followed by partial nephrectomy

Arm I

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Postoperative Complications; Carcinoma, Renal Cell

Interventions

Cold Ischemia; Warm Ischemia

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Tissue Preservation; Preservation, Biological; Investigative Techniques

Study Officials

• Joseph A. Pettus, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)