Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
- Conditions
- Liver Cancer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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)
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Scroll for more (8 remaining)Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham🇺🇸Birmingham, Alabama, United States