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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer

Conditions
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Kidney Cancer

Intervention / Treatment
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* Procedure: laparoscopic surgery
* Procedure: radiofrequency ablation
* Procedure: thermal ablation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic surgery|nan|
|Procedure: radiofrequency ablation|nan|
|Procedure: thermal ablation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I renal cell cancer, stage II renal cell cancer