Status:
COMPLETED
Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
Lead Sponsor:
American College of Radiology Imaging Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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 a...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00132041
Start Date
December 1 2005
End Date
November 1 2010
Last Update
September 10 2020
Active Locations (18)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
4
University of California Davis Cancer Center
Sacramento, California, United States, 95817