Metastatic Cancer Clinical Trial
Official title:
A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors
RATIONALE: Heating tumors to several degrees above body temperature may kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of heat therapy in treating patients who
have unresectable primary or metastatic liver cancer.
OBJECTIVES: I. Determine the efficacy of radiofrequency ablation in patients with primary or
metastatic liver cancer. II. Determine disease free survival, local recurrence rate in
treated lesions as compared to known recurrence rates after hepatic cryoablation, and overall
survival in this patient population receiving this regimen.
OUTLINE: Patients undergo laparoscopic or open laparotomy surgical procedure to identify
unresectable tumors by ultrasound. Tumors are heated to a target temperature by electrodes
for a maximum of 20 minutes. To achieve a 1 cm margin of ablated tissue around each lesion,
multiple ablation courses may be performed, depending on the size of the lesions and the time
required to complete the treatment. Patients may be retreated if tumor recurs or new disease
appears. Patients are followed at 1 month, every 3 months for the first 2 years, every 6
months for next 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 59 patients will be accrued for this study.
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