Radiofrequency Ablation in Treating Patients With Liver Cancer and Cirrhosis
NCT ID: NCT00132041
Last Updated: 2020-09-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
51 participants
INTERVENTIONAL
2005-12-31
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with liver cancer and cirrhosis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
NCT00019604
Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)
NCT01669668
Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation
NCT01340105
Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma
NCT00554905
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases
NCT00510627
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All Patients
patients with cirrhosis undergoing solitary or repetitive percutaneous RFA treatment sessions for the treatment of HCC.
radiofrequency ablation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
radiofrequency ablation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerald D. Dodd, MD
Role: STUDY_CHAIR
The University of Texas Health Science Center at San Antonio
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 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
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
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Cancer Institute
Temple, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACRIN-6673
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000439446
Identifier Type: -
Identifier Source: org_study_id
NCT00399958
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.