Kidney Cancer Clinical Trial
Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)
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).
Full 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 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
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There is 1 Location for this study
Bethesda Maryland, 20892, United States
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