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Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)
This study has been completed.
Study NCT00019955   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
March 2000
 
Response [ Designated as safety issue: No ]
Response
Complete list of historical versions of study NCT00019955 on ClinicalTrials.gov Archive Site
 
 
 
Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)
A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer

RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature.

PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma (kidney cancer).

OBJECTIVES:

Primary

  • Evaluate the efficacy of radiofrequency interstitial tissue ablation in terms of tumor destruction or slowed tumor growth rate in patients with localized renal cell carcinoma.

Secondary

  • Assess the toxicity of this treatment regimen in these patients.

OUTLINE: Patients undergo percutaneous radiofrequency interstitial tumor ablation (RFA). Patients are offered laparoscopy-assisted percutaneous RFA in the operating room if their tumors are not safely accessible. Intra-operative ultrasound is used to confirm probe placement and to monitor treatment delivery. If the target temperature or impedance are not reached, treatment is repeated no more than twice. No more than 5 tumors are treated per kidney.

All patients are followed at 2 to 3 months, 6 months, and then at 1 year.

Patients with tumors greater than 2 cm in diameter are followed every 6 months for up to 5 years. Patients whose tumors become greater than 3 cm are recommended for surgery and removed from study if surgery is performed.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 1 year.

Phase II
Interventional
Treatment, Open Label
Kidney Cancer
  • Procedure: laparoscopic surgery
  • Procedure: radiofrequency ablation
  • Procedure: thermal ablation therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Localized renal cell carcinoma, meeting both of the following criteria:

    • Enlarging renal tumors on imaging studies over a minimum of 12 months
    • Tumor size between 0.5-4.0 cm in diameter at time of treatment

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Other:

  • Not pregnant
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specifed

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019955
 
CDR0000067334, NCI-99-C-0170
National Cancer Institute (NCI)
 
Study Chair: McClellan M. Walther, MD NCI - Urologic Oncology Branch
National Cancer Institute (NCI)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP