Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

Not Applicable

Completed

• Conditions: Liver Cancer
• Interventions: Device: radiofrequency ablation

• Registration Number: NCT00132041
• Lead Sponsor: American College of Radiology Imaging Network

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 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.

Study Timeline

• Study First Submitted: 2005-08-16
• Study First Submitted QC: 2005-08-16
• Study First Posted: 2005-08-19
• Study Start: 2005-12
• Primary Completion: 2009-08
• Study Completion: 2010-11
• Results First Submitted: 2019-07-02
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-21
• Last Update Submitted: 2020-08-21
• Results First Posted: 2020-09-10
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	radiofrequency ablation	patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Successful Control of Disease at 18 Months	18 months after start of therapy	Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months.

Secondary Outcome Measures

Name	Time	Method
Local Tumor Recurrence (Control) Rates	18 months after start of therapy	local tumor control rate is defined as a tumor that was ablated and was not seen again within the 18 month period
Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation	18 months after start of therapy	this outcome measures the impact of Solitary vs repetitive radiofrequency ablation on success.; Success is defined as the number of patients centrally determined to be alive and tumor-free 18 months after start of therapy, corrected for repetitive RFA.
Effect of Tumor Size on Successful Control of Disease at 18 Months	18 months after start of therapy	Outcome is positive (success) if alive and no disease is observed by CT at 18 months post start of therapy Outcome is negative if the patient was deceased or disease was observed by CT at 18 months post start of therapy Success rate it the fraction of eligible patients who were alive and disease free at 18 months. Tumor size is a continuous variable as measured at imaging.
Impact of Tumor Size on Local Control Rates	18 months after start of therapy	Lesion level local control is defined as a success if a tumor is ablated and does not recur in 18 mo.
Development of Extra-hepatic Tumor	18 months after start of therapy	Whether or not extrahepatic tumors were seen at 18months post ablation will be compared with the number of RFA sessions.
Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan	18 months after start of therapy	the primary outcome was evidence of existing tumor on pathologic review of the liver at the time or transplant or autopsy within the 18 month observational period. This outcome was compared to the CT HCC detection.
Remote Tumor Occurrence Rates	18 months after start of therapy	remote tumor occurrence rate is defined as a new intrahepatic tumor that developed remote from the ablation site within the 18 month period

Trial Locations

Locations (18)

Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

William Beaumont Hospital - Royal Oak Campus; 🇺🇸 Royal Oak, Michigan, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UMASS Memorial Cancer Center - University Campus; 🇺🇸 Worcester, Massachusetts, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Rhode Island Hospital Comprehensive Cancer Center; 🇺🇸 Providence, Rhode Island, United States

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

Scott and White Cancer Institute; 🇺🇸 Temple, Texas, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States