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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laparoscopic surgery
radiofrequency ablation
thermal ablation therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage I renal cell cancer, stage II renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019955
Brief Title
Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)
Official Title
A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage I renal cell cancer, stage II renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
thermal ablation therapy
Primary Outcome Measure Information:
Title
Response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McClellan M. Walther, MD
Organizational Affiliation
NCI - Urologic Oncology Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14733831
Citation
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.
Results Reference
background
PubMed Identifier
12431330
Citation
Pautler SE, Walther MM. Transperitoneal laparoscopic radical nephrectomy for bulky renal tumors. Can J Urol. 2002 Oct;9(5):1653-9; discussion 1660.
Results Reference
background
PubMed Identifier
12459621
Citation
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.
Results Reference
background
PubMed Identifier
11900230
Citation
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.
Results Reference
background
PubMed Identifier
15383844
Citation
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.
Results Reference
background
PubMed Identifier
11564277
Citation
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.
Results Reference
background
PubMed Identifier
15231890
Citation
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.
Results Reference
background
PubMed Identifier
11309443
Citation
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.
Results Reference
background
PubMed Identifier
15076283
Citation
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.
Results Reference
result
PubMed Identifier
11743264
Citation
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.
Results Reference
result
PubMed Identifier
10751849
Citation
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.
Results Reference
result

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

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