NCT00132041

Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DEVICE	radiofrequency ablation

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-08-01
• Completion: 2010-11-01
• First posted: 2005-08-19
• Last updated: 2020-09-10
• Results posted: 2020-09-10

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study