<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01669668</url>
  </required_header>
  <id_info>
    <org_study_id>201207113</org_study_id>
    <nct_id>NCT01669668</nct_id>
  </id_info>
  <brief_title>Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)</brief_title>
  <official_title>Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how effectively radiofrequency ablation prevents recurrence of&#xD;
      hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency&#xD;
      ablation uses a high-frequency, electric current to kill tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of referrals.&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local recurrence, defined as the recurrence at the size of original tumor</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Local recurrence will be summarized using descriptive statistics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity and mortality associated with RFA under ideal conditions</measure>
    <time_frame>30 days</time_frame>
    <description>The incidences of surgical complications and procedure-related death will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>At 2 years</time_frame>
    <description>Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival rate</measure>
    <time_frame>At 2 years</time_frame>
    <description>Kaplan-Meier product limit method will be used to estimate the 2-year disease-free survival. The median disease-free survival will also be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of patients who develop recurrence to undergo salvage transplantation</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>At the time of recurrence, the patient is evaluated to see if she/he falls within the Milan criteria; if she/he does, then she/he is considered able to undergo salvage transplantation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>RFA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo laparoscopic ultrasound followed by RFA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency ablation</intervention_name>
    <description>Undergo RFA</description>
    <arm_group_label>RFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopy</intervention_name>
    <description>Undergo laparoscopic ultrasound</description>
    <arm_group_label>RFA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven HCC or unambiguous radiologic findings consistent with HCC (&gt; 1&#xD;
             cm tumor with arterial hypervascularity and venous or delayed phase washout) in&#xD;
             patients with underlying liver disease.&#xD;
&#xD;
          -  Disease must be considered unresectable (as defined by protocol).&#xD;
&#xD;
          -  Age between 18 and 69 (inclusive).&#xD;
&#xD;
          -  Karnofsky performance status of ≥ 80%&#xD;
&#xD;
          -  Normal organ and marrow function as defined below:&#xD;
&#xD;
          -  leukocytes ≥3,000/mcL&#xD;
&#xD;
          -  absolute neutrophil count ≥1,500/mcL&#xD;
&#xD;
          -  platelets &gt;100,000/mcL&#xD;
&#xD;
          -  total bilirubin &lt;2.0 mg/dL&#xD;
&#xD;
          -  AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal&#xD;
&#xD;
          -  creatinine within normal institutional limits OR&#xD;
&#xD;
          -  creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above&#xD;
             institutional normal&#xD;
&#xD;
          -  Presence of ≤ 3 tumors, all of which are ≤ 3 cm in size. This will be determined&#xD;
             preoperatively and confirmed by intraoperative ultrasound.&#xD;
&#xD;
          -  Liver function of Child-Pugh class A or B&#xD;
&#xD;
          -  Tumor(s) must be more than 2 cm away from of major biliary duct or major blood vessel&#xD;
             defined as the main portal vein and its right and left primary branches and the first&#xD;
             1 cm of the secondary branches of the common hepatic duct and its right and left&#xD;
             primary branches or the first 1 cm of its secondary branches.&#xD;
&#xD;
          -  Able to understand and willing to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor&#xD;
             which is within 2 cm of the tumor being assessed for treatment and which has a&#xD;
             diameter of less than 33% of the diameter of the tumor being assessed for treatment.&#xD;
&#xD;
          -  Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed&#xD;
             within 4 weeks of the procedure.&#xD;
&#xD;
          -  Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic&#xD;
             disease is discovered at this laparoscopy, RFA will not be performed, and the patient&#xD;
             will be considered ineligible for this study and will be replaced.&#xD;
&#xD;
          -  Pregnancy. All women of childbearing potential must have a negative pregnancy test&#xD;
             prior to enrollment in the study.&#xD;
&#xD;
          -  Significant portal hypertension based on evidence of esophageal varices or ascites.&#xD;
             Minimal portal hypertension or ascites will not be an exclusion criterion.&#xD;
&#xD;
          -  Previous history of HCC or any other non-cutaneous malignancy.&#xD;
&#xD;
        Patients who are found to be ineligible due to intraoperative findings will be recorded as&#xD;
        to the cause of ineligibility. They will not be counted as accrued patients.&#xD;
&#xD;
        -Inclusion of Women and Minorities Both men and women and members of all races and ethnic&#xD;
        groups are eligible for this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Strasberg, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669668
org study id: 201207113
nct id: NCT01669668
lead sponsor: 
has dmc: No
This phase II trial studies how effectively radiofrequency ablation prevents recurrence of
      hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency
      ablation uses a high-frequency, electric current to kill tumor cells.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local recurrence, defined as the recurrence at the size of original tumor
time frame: Up to 2 years
description: Local recurrence will be summarized using descriptive statistics.
measure: Morbidity and mortality associated with RFA under ideal conditions
time frame: 30 days
description: The incidences of surgical complications and procedure-related death will be calculated.
measure: Overall survival rate
time frame: At 2 years
description: Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be
measure: Disease-free survival rate
time frame: At 2 years
description: Kaplan-Meier product limit method will be used to estimate the 2-year disease-free survival. The median disease-free survival will also be estimated.
measure: Ability of patients who develop recurrence to undergo salvage transplantation
time frame: Up to 2 years
description: At the time of recurrence, the patient is evaluated to see if she/he falls within the Milan criteria; if she/he does, then she/he is considered able to undergo salvage transplantation.
arm group label: RFA
arm group type: Experimental
description: Patients undergo laparoscopic ultrasound followed by RFA.
intervention type: Procedure
intervention name: radiofrequency ablation
description: Undergo RFA
arm group label: RFA
intervention type: Procedure
intervention name: laparoscopy
description: Undergo laparoscopic ultrasound
arm group label: RFA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Steven Strasberg, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular