<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/NCT01677468</url>
  </required_header>
  <id_info>
    <org_study_id>2011-12-122</org_study_id>
    <nct_id>NCT01677468</nct_id>
  </id_info>
  <brief_title>Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma</brief_title>
  <official_title>Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hallym University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate whether survival of patients who underwent TACE with&#xD;
      unresectable HCC can benefit from intermediate-levels of embolization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjective angiographic chemoembolization endpoints (SACE) levels were developed to&#xD;
      standardize the embolic endpoints of transarterial chemoembolization (TACE) for&#xD;
      hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor&#xD;
      blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none.&#xD;
      SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates&#xD;
      overembolization. The aim of this study was to evaluate whether survival of patients who&#xD;
      underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate of the subjects</measure>
    <time_frame>6 months after TACE</time_frame>
    <description>Survival rate of the subjects 6 months after TACE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival rate of the subjects</measure>
    <time_frame>12 months after TACE</time_frame>
    <description>Survival rate of the subjects, 12 months after TACE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival rate of the subjects</measure>
    <time_frame>18 months after TACE</time_frame>
    <description>Survival rate of the subjects, 18 months after TACE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival rate of the subjects</measure>
    <time_frame>24 months after TACE</time_frame>
    <description>Survival rate of the subjects, 24 months after TACE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival of the subjects</measure>
    <time_frame>6, 12, 18, and 24 months after TACE</time_frame>
    <description>Disease free survival of the subjects, 24 months after TACE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate of TACE</measure>
    <time_frame>6, 12, 18, and 24 months after TACE</time_frame>
    <description>The incidence of infection, hemorrhage, 24 months after TACE</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Transarterial Chemoembolization</condition>
  <arm_group>
    <arm_group_label>Intermediate embolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TACE with substatsis using gelfoam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete embolization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TACE with complete embolization using gelfoam</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intermediate embolization</intervention_name>
    <description>TACE with substasis using gelfoam</description>
    <arm_group_label>Intermediate embolization</arm_group_label>
    <other_name>Adriamycin</other_name>
    <other_name>Cysplatin</other_name>
    <other_name>Gelfoam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complete embolization</intervention_name>
    <description>TACE with complete embolization using gelfoam</description>
    <arm_group_label>Complete embolization</arm_group_label>
    <other_name>Adriamycin</other_name>
    <other_name>Cysplatin</other_name>
    <other_name>Gelfoam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Hepatocellular carcinoma diagnosed histologically or clinically&#xD;
&#xD;
          -  Tumor numbers of 5 or less&#xD;
&#xD;
          -  No history of treatment for hepatocellular carcinoma&#xD;
&#xD;
          -  Patients with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extrahepatic metastasis&#xD;
&#xD;
          -  Rupture of hepatocellular carcinoma&#xD;
&#xD;
          -  Infiltrative hepatocellular carcinoma&#xD;
&#xD;
          -  Malignancy other than hepatocellular carcinoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang Hoon Park, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sang Hoon Park, M.D., Ph.D.</last_name>
    <phone>82-2-829-5493</phone>
    <email>dr.sanghoon.park@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Su Rin Shin, M.D.</last_name>
    <phone>82-2-829-5490</phone>
    <email>dr.goforit@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hallym Sacred Heart Hospital</name>
      <address>
        <city>Anyang</city>
        <zip>431070</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Choong Kee Park, M.D., Ph.D.</last_name>
      <phone>82-31-380-3708</phone>
      <email>ckp@hallym.or.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chuncheon Sacred Heart Hospital</name>
      <address>
        <city>Chuncheon</city>
        <zip>200060</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong Joon Kim, M.D., Ph.D.</last_name>
      <phone>82-33-741-1226</phone>
      <email>djkim@hallym.ac.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kangnam Sacred Heart Hostpita</name>
      <address>
        <city>Seoul</city>
        <zip>150950</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang Hoon Park, M.D., Ph.D.</last_name>
      <phone>82-2-829-5493</phone>
      <email>dr.sanghoon.park@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Sang Hoon Park, M.D., Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Transarterial chemoembolization</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Gelatin Sponge, Absorbable</mesh_term>
  </intervention_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/NCT01677468
org study id: 2011-12-122
nct id: NCT01677468
lead sponsor: 
has dmc: No
The aim of this study was to evaluate whether survival of patients who underwent TACE with
      unresectable HCC can benefit from intermediate-levels of embolization.
Subjective angiographic chemoembolization endpoints (SACE) levels were developed to
      standardize the embolic endpoints of transarterial chemoembolization (TACE) for
      hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor
      blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none.
      SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates
      overembolization. The aim of this study was to evaluate whether survival of patients who
      underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Survival rate of the subjects
time frame: 6 months after TACE
description: Survival rate of the subjects 6 months after TACE
measure: Survival rate of the subjects
time frame: 12 months after TACE
description: Survival rate of the subjects, 12 months after TACE
measure: Survival rate of the subjects
time frame: 18 months after TACE
description: Survival rate of the subjects, 18 months after TACE
measure: Survival rate of the subjects
time frame: 24 months after TACE
description: Survival rate of the subjects, 24 months after TACE
measure: Disease free survival of the subjects
time frame: 6, 12, 18, and 24 months after TACE
description: Disease free survival of the subjects, 24 months after TACE
measure: Complication rate of TACE
time frame: 6, 12, 18, and 24 months after TACE
description: The incidence of infection, hemorrhage, 24 months after TACE
arm group label: Intermediate embolization
arm group type: Experimental
description: TACE with substatsis using gelfoam
arm group label: Complete embolization
arm group type: Active Comparator
description: TACE with complete embolization using gelfoam
intervention type: Procedure
intervention name: Intermediate embolization
description: TACE with substasis using gelfoam
arm group label: Intermediate embolization
other name: Adriamycin
other name: Cysplatin
other name: Gelfoam
intervention type: Procedure
intervention name: Complete embolization
description: TACE with complete embolization using gelfoam
arm group label: Complete embolization
other name: Adriamycin
other name: Cysplatin
other name: Gelfoam
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sang Hoon Park, M.D., Ph.D.
role: Principal Investigator
affiliation: Hallym University Medical Center
last name: Sang Hoon Park, M.D., Ph.D.
phone: 82-2-829-5493
email: dr.sanghoon.park@gmail.com
last name: Su Rin Shin, M.D.
phone: 82-2-829-5490
email: dr.goforit@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Gelatin Sponge, Absorbable