Liver Cancer Clinical Trial
Official title:
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor
cells. CT-, MRI-, or ultrasound-guided radiofrequency ablation may be an effective treatment
for liver cancer and cirrhosis.
PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating
patients with liver cancer and cirrhosis.
OBJECTIVES:
Primary
- Determine the 18-month successful disease control rate, defined as no identifiable liver
tumor by CT scan, in patients with hepatocellular carcinoma and cirrhosis treated with
solitary or repetitive percutaneous radiofrequency ablation (RFA).
Secondary
- Correlate tumor size, MELD score, and the number of RFA treatments (solitary or
repetitive) with the 18-month successful disease control rate in patients treated with
this procedure.
- Determine the local and remote intrahepatic and extrahepatic tumor recurrence rates in
patients treated with this procedure.
- Correlate local and remote intrahepatic and extrahepatic tumor recurrence rates with the
18-month successful disease control rate in patients treated with this procedure.
- Correlate tumor size with the local disease control rate in patients treated with this
procedure.
- Correlate solitary or repetitive RFA with or without local/regional tumor control with
the development of extrahepatic tumor in these patients.
- Determine the local tumor eradication rate, as determined by examination of whole liver
specimens or CT scan, in patients treated with this procedure.
OUTLINE: This is a multicenter study. Patients are stratified according to hepatic
dysfunction using the MELD score (< 15 vs 15-25 vs > 25).
Patients undergo placement of an ablation electrode percutaneously into the tumor(s) by CT
scan, MRI, or ultrasound guidance. Patients then undergo percutaneous radiofrequency ablation
(RFA) directly to the tumor(s) for 12 minutes. Patients undergo CT scan of the liver within 1
week after RFA treatment and then every 3 months for up to 18 months. Patients with residual
or recurrent intrahepatic tumor(s) detectable on the 3-month or subsequent CT scan undergo
repeat RFA as is technically feasible and clinically indicated for up to 15 months after
initial RFA treatment.
After completion of study treatment, patients are followed at 1 day, 1 week, 1 month, and
then every 3 months for up to 18 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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