Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
- 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).
- 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
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
No identifiable tumor by CT scan 18 months after start of therapy
Gerald D. Dodd, MD
University of Texas Health Science Center at San Antonio
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|UMASS Memorial Cancer Center - University Campus||Worcester, Massachusetts 01605-2982|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Rhode Island Hospital Comprehensive Cancer Center||Providence, Rhode Island 02903|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center||Los Angeles, California 90048-1865|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham||Birmingham, Alabama 35294|
|Scott and White Cancer Institute||Temple, Texas 76508|