Overview

This trial is active, not recruiting.

Condition liver cancer
Treatment radiofrequency ablation
Phase phase 2
Sponsor American College of Radiology Imaging Network
Collaborator National Cancer Institute (NCI)
Start date December 2005
Trial size 40 participants
Trial identifier NCT00132041, ACRIN-6673, CDR0000439446, NCT00399958

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 and cirrhosis.

PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
No identifiable tumor by CT scan 18 months after start of therapy
time frame:

Secondary Outcomes

Measure
Solitary vs repetitive radiofrequency ablation Impact on the primary objective 18 months after start of therapy
time frame:
Tumor size impact on the primary objective 18 months after start of therapy
time frame:
Correlate Model for End-Stage Liver Disease (MELD) score and the primary objective 18 months after start of therapy
time frame:
Local and remote tumor recurrence rates 18 months after start of therapy
time frame:
Impact of tumor size on local control rates 18 months after start of therapy
time frame:
Impact of solitary or repetitive radiofrequency ablation (RFA) with or without local control on development of extra-hepatic tumor
time frame:
Local tumor eradication rate by examination of liver via autopsy or transplant vs that determined by CT scan
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).