Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis (ACRIN-6673)
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer
Eligibility 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
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center at UCLA
- University of California Davis Cancer Center
- Winship Cancer Institute of Emory University
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- UMASS Memorial Cancer Center - University Campus
- William Beaumont Hospital - Royal Oak Campus
- Mayo Clinic Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Wake Forest University Comprehensive Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Rhode Island Hospital Comprehensive Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- M. D. Anderson Cancer Center at University of Texas
- University of Texas Health Science Center at San Antonio
- Scott and White Cancer Institute
Arms of the Study
Arm 1
Other
All Patients
patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.