Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients|
- No identifiable tumor by CT scan 18 months after start of therapy
- Solitary vs repetitive radiofrequency ablation Impact on the primary objective 18 months after start of therapy
- Tumor size impact on the primary objective 18 months after start of therapy
- Correlate Model for End-Stage Liver Disease (MELD) score and the primary objective 18 months after start of therapy
- Local and remote tumor recurrence rates 18 months after start of therapy
- Impact of tumor size on local control rates 18 months after start of therapy
- Impact of solitary or repetitive radiofrequency ablation (RFA) with or without local control on development of extra-hepatic tumor
- Local tumor eradication rate by examination of liver via autopsy or transplant vs that determined by CT scan
|Study Start Date:||December 2005|
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132041
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|UMASS Memorial Cancer Center - University Campus|
|Worcester, Massachusetts, United States, 01655|
|United States, Michigan|
|William Beaumont Hospital - Royal Oak Campus|
|Royal Oak, Michigan, United States, 48073|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Rhode Island|
|Rhode Island Hospital Comprehensive Cancer Center|
|Providence, Rhode Island, United States, 02903|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Scott and White Cancer Institute|
|Temple, Texas, United States, 76508|
|Study Chair:||Gerald D. Dodd, MD||The University of Texas Health Science Center at San Antonio|