- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019955
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: McClellan M. Walther, MD, NCI - Urologic Oncology Branch
Publications and helpful links
General Publications
- Hwang JJ, Walther MM. Update on minimally invasive approaches to kidney tumors. Curr Urol Rep. 2004 Feb;5(1):13-8. doi: 10.1007/s11934-004-0005-y.
- Pautler SE, Walther MM. Transperitoneal laparoscopic radical nephrectomy for bulky renal tumors. Can J Urol. 2002 Oct;9(5):1653-9; discussion 1660.
- 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. doi: 10.1097/00000478-200212000-00002.
- Wood BJ, Ramkaransingh JR, Fojo T, Walther MM, Libutti SK. Percutaneous tumor ablation with radiofrequency. Cancer. 2002 Jan 15;94(2):443-51. doi: 10.1002/cncr.10234.
- 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. doi: 10.1007/s00270-004-0062-0. Epub 2004 Jun 3.
- 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. doi: 10.1097/01.rvi.0000133535.16753.58.
- 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. doi: 10.1093/jnci/93.8.648. No abstract available.
- 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. doi: 10.1097/01.ju.0000119905.72574.de.
- Pavlovich CP, Walther M, 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067334
- NCI-99-C-0170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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