We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00132041
Recruitment Status : Unknown
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2005
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Procedure: radiofrequency ablation Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients
Study Start Date : December 2005

Primary Outcome Measures :
  1. No identifiable tumor by CT scan 18 months after start of therapy

Secondary Outcome Measures :
  1. Solitary vs repetitive radiofrequency ablation Impact on the primary objective 18 months after start of therapy
  2. Tumor size impact on the primary objective 18 months after start of therapy
  3. Correlate Model for End-Stage Liver Disease (MELD) score and the primary objective 18 months after start of therapy
  4. Local and remote tumor recurrence rates 18 months after start of therapy
  5. Impact of tumor size on local control rates 18 months after start of therapy
  6. Impact of solitary or repetitive radiofrequency ablation (RFA) with or without local control on development of extra-hepatic tumor
  7. Local tumor eradication rate by examination of liver via autopsy or transplant vs that determined by CT scan

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • No uncorrectable coagulopathy


  • Not specified


  • Creatinine ≤ 2.0 mg/dL


  • 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)


Biologic therapy

  • Not specified


  • No prior or concurrent chemotherapy for HCC
  • No prior or concurrent chemoembolization for HCC

Endocrine therapy

  • Not specified


  • No prior or concurrent radiotherapy for HCC


  • No prior choledochoenteric anastomosis
  • No prior sphincterotomy of duodenal papilla


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Gerald D. Dodd, MD The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier: NCT00132041     History of Changes
Obsolete Identifiers: NCT00399958
Other Study ID Numbers: CDR0000439446
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: November 2007

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases