Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer) - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019955

Purpose

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).

Condition	Intervention	Phase
Kidney Cancer	Procedure: laparoscopic surgery Procedure: radiofrequency ablation Procedure: thermal ablation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response [ Designated as safety issue: No ]

Study Start Date:

March 2000

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019955

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

McClellan M. Walther, MD

NCI - Urologic Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hwang JJ, Walther MM, Pautler SE, Coleman JA, Hvizda J, Peterson J, Linehan WM, Wood BJ. Radio frequency ablation of small renal tumors:: intermediate results. J Urol. 2004 May;171(5):1814-8.

Pavlovich CP, Walther MM, Choyke PL, Pautler SE, Chang R, Linehan WM, Wood BJ. Percutaneous radio frequency ablation of small renal tumors: initial results. J Urol. 2002 Jan;167(1):10-5.

Walther MC, Shawker TH, Libutti SK, Lubensky I, Choyke PL, Venzon D, Linehan WM. A phase 2 study of radio frequency interstitial tissue ablation of localized renal tumors. J Urol. 2000 May;163(5):1424-7.

Hwang JJ, Walther MM. Update on minimally invasive approaches to kidney tumors. Curr Urol Rep. 2004 Feb;5(1):13-8. Review.

Pautler SE, Walther MM. Transperitoneal laparoscopic radical nephrectomy for bulky renal tumors. Can J Urol. 2002 Oct;9(5):1653-9; discussion 1660. Review.

Pavlovich CP, Walther MM, Eyler RA, Hewitt SM, Zbar B, Linehan WM, Merino MJ. Renal tumors in the Birt-Hogg-Dube syndrome. Am J Surg Pathol. 2002 Dec;26(12):1542-52.

Wood BJ, Ramkaransingh JR, Fojo T, Walther MM, Libutti SK. Percutaneous tumor ablation with radiofrequency. Cancer. 2002 Jan 15;94(2):443-51. Review.

Friedman M, Mikityansky I, Kam A, Libutti SK, Walther MM, Neeman Z, Locklin JK, Wood BJ. Radiofrequency ablation of cancer. Cardiovasc Intervent Radiol. 2004 Sep-Oct;27(5):427-34. Epub 2004 Jun 3. Review.

Pautler SE, Pavlovich CP, Mikityansky I, Drachenberg DE, Choyke PL, Linehan WM, Wood BJ, Walther MM. Retroperitoneoscopic-guided radiofrequency ablation of renal tumors. Can J Urol. 2001 Aug;8(4):1330-3.

Kam AW, Littrup PJ, Walther MM, Hvizda J, Wood BJ. Thermal protection during percutaneous thermal ablation of renal cell carcinoma. J Vasc Interv Radiol. 2004 Jul;15(7):753-8.

Pacak K, Fojo T, Goldstein DS, Eisenhofer G, Walther MM, Linehan WM, Bachenheimer L, Abraham J, Wood BJ. Radiofrequency ablation: a novel approach for treatment of metastatic pheochromocytoma. J Natl Cancer Inst. 2001 Apr 18;93(8):648-9. No abstract available.

Study ID Numbers:	CDR0000067334, NCI-99-C-0170
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00019955 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I renal cell cancer
stage II renal cell cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009