Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

Liver Cancer Clinical Trial

— ACRIN-6673  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132041
• Other study ID #: CDR0000439446
• Secondary ID: ACRIN-6673U01CA0
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Est. completion date: November 2010

Study information

• Verified date: August 2020
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00399958

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• radiofrequency ablation

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
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	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	University of California Davis Cancer Center	Sacramento	California
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Scott and White Cancer Institute	Temple	Texas
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Successful Control of Disease at 18 Months	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.	18 months after start of therapy
Secondary	Number of Participants With Success in Those Who Received Solitary vs Repetitive Radiofrequency Ablation	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.	18 months after start of therapy
Secondary	Effect of Tumor Size on Successful Control of Disease at 18 Months	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.	18 months after start of therapy
Secondary	Local Tumor Recurrence (Control) Rates	local tumor control rate is defined as a tumor that was ablated and was not seen again within the 18 month period	18 months after start of therapy
Secondary	Impact of Tumor Size on Local Control Rates	Lesion level local control is defined as a success if a tumor is ablated and does not recur in 18 mo.	18 months after start of therapy
Secondary	Development of Extra-hepatic Tumor	Whether or not extrahepatic tumors were seen at 18months post ablation will be compared with the number of RFA sessions.	18 months after start of therapy
Secondary	Local Tumor Eradication Rate by Examination of Liver Via Autopsy or Transplant vs That Determined by CT Scan	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.	18 months after start of therapy
Secondary	Remote Tumor Occurrence Rates	remote tumor occurrence rate is defined as a new intrahepatic tumor that developed remote from the ablation site within the 18 month period	18 months after start of therapy

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database