A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of Radiofrequency Ablation in Patients with Primary or Metastatic Liver Cancer
Steven A. Curley, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|