Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00132041
First received: August 16, 2005
Last updated: February 6, 2009
Last verified: November 2007
  Purpose

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 Intervention Phase
Liver Cancer
Procedure: radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Feasibility Study of Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • No identifiable tumor by CT scan 18 months after start of therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solitary vs repetitive radiofrequency ablation Impact on the primary objective 18 months after start of therapy [ Designated as safety issue: No ]
  • Tumor size impact on the primary objective 18 months after start of therapy [ Designated as safety issue: No ]
  • Correlate Model for End-Stage Liver Disease (MELD) score and the primary objective 18 months after start of therapy [ Designated as safety issue: No ]
  • Local and remote tumor recurrence rates 18 months after start of therapy [ Designated as safety issue: No ]
  • Impact of tumor size on local control rates 18 months after start of therapy [ Designated as safety issue: No ]
  • Impact of solitary or repetitive radiofrequency ablation (RFA) with or without local control on development of extra-hepatic tumor [ Designated as safety issue: No ]
  • Local tumor eradication rate by examination of liver via autopsy or transplant vs that determined by CT scan [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132041

Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Investigators
Study Chair: Gerald D. Dodd, MD The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00132041     History of Changes
Obsolete Identifiers: NCT00399958
Other Study ID Numbers: CDR0000439446, ACRIN-6673
Study First Received: August 16, 2005
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 19, 2014