Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
18 Years
N/A
Both
Liver Cancer
Trial Information
Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of hepatocellular carcinoma (HCC), meeting 1 of the following criteria:
- Histologically confirmed HCC
- Discrete non-biopsied hepatic tumors, meeting 1 of the following criteria:
- Hypervascular tumor > 2 cm by 2 imaging studies
- Hypervascular tumor > 2 cm by a single imaging study AND alpha-fetoprotein
≥ 400 ng/mL
- Discrete non-biopsied hypervascular hepatic tumors by 2 consecutive imaging
studies (e.g., CT scan or MRI) with documented tumor growth > 1 cm in diameter
- Histologically confirmed cirrhosis OR typical findings of cirrhosis (i.e., nodular
liver, splenomegaly, varices, or ascites) by CT scan and/or MRI scan
- Single hepatic tumor > 3.0 cm but ≤ 5.0 cm in diameter OR 3 or fewer hepatic tumors ≤
3.0 cm in diameter
- No excessive intrahepatic tumor burden (i.e., > 3 hepatic tumors OR a single
hepatic tumor > 5 cm OR more than 3 vague hypervascular nodules > 1 cm)
- Tumor(s) ≥ 1 cm from the main, right, and left portal veins and hollow viscera
- No hepatic or portal vein tumor invasion
- Tumor(s) > 1 cm treatable by percutaneous radiofrequency ablation
- No extrahepatic tumor
- Not a surgical candidate due to any of the following reasons:
- Tumor in an unresectable location
- Comorbid disease
- Insufficient hepatic reserve
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- No uncorrectable coagulopathy
Hepatic
- Not specified
Renal
- Creatinine ≤ 2.0 mg/dL
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active symptomatic bacterial or fungal infection that is newly diagnosed and/or
requires treatment
- No absolute contraindication to IV iodinated contrast (i.e., history of significant
contrast reaction not mitigated by appropriate premedication)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior or concurrent chemotherapy for HCC
- No prior or concurrent chemoembolization for HCC
Endocrine therapy
- Not specified
Radiotherapy
- No prior or concurrent radiotherapy for HCC
Surgery
- No prior choledochoenteric anastomosis
- No prior sphincterotomy of duodenal papilla
Other
- No prior or concurrent cryoablation for HCC
- No other prior or concurrent therapy for HCC
- At least 7 days since prior aspirin
- At least 24 hours since prior ibuprofen
- At least 12 hours since prior low molecular weight heparin preparations
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
No identifiable tumor by CT scan 18 months after start of therapy
Safety Issue:
No
Principal Investigator
Gerald D. Dodd, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas Health Science Center at San Antonio
Authority:
United States: Federal Government
Study ID:
CDR0000439446
NCT ID:
NCT00132041
Start Date:
December 2005
Completion Date:
Related Keywords:
- Liver Cancer
- adult primary hepatocellular carcinoma
- localized unresectable adult primary liver cancer
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| 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 |
