<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/NCT01686880</url>
  </required_header>
  <id_info>
    <org_study_id>TRYPHON</org_study_id>
    <nct_id>NCT01686880</nct_id>
  </id_info>
  <brief_title>Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver</brief_title>
  <acronym>TRYPHON</acronym>
  <official_title>Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jules Bordet Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jules Bordet Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety of transarterial radioembolization prior to&#xD;
      surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the peri-operative morbidity and mortality of&#xD;
      supraselective ablative transarterial radioembolization prior to surgical resection or&#xD;
      radiofrequency in cirrhotic patients with HCC&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    poor recruitment and an unexpected low treatment rate&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Peri-operative morbidity</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>3 years</time_frame>
    <description>Assessment of the overall disease free survival and Overall Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One and three years survival</measure>
    <time_frame>one and three years</time_frame>
    <description>Estimation of disease free survival and overall survival rates after 1 and 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor regression</measure>
    <time_frame>8 weeks after Trans-arterial radioembolization</time_frame>
    <description>Assessment of tumour size regression after Trans-arterial radioembolization by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Imaging</measure>
    <time_frame>3 years</time_frame>
    <description>Assessment of imaging parameters changes (DW-MRI, FDG-PET/CT) and MAA-SPECT-CT in relation to the outcome measured by tumour regression after TARE, disease free and overall survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contra-lateral Lobe Hypertrophy</measure>
    <time_frame>3 Years</time_frame>
    <description>Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Preoperative aTARE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sirsphere trans-arterial radioembolization</intervention_name>
    <description>Patients will receive Sirsphere trans-arterial radioembolization before surgery</description>
    <arm_group_label>Preoperative aTARE</arm_group_label>
    <other_name>TARE</other_name>
    <other_name>SIRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver&#xD;
             biopsy.&#xD;
&#xD;
          -  HCC with at least one lesion measuring more than 1 cm in diameter with a single&#xD;
             dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by&#xD;
             washout of contrast in the venous-delayed phases, or diagnosed by biopsy.&#xD;
&#xD;
          -  Borderline resectable disease eligible for surgical resection or radiofrequency&#xD;
             destruction.&#xD;
&#xD;
          -  No extra-hepatic dissemination.&#xD;
&#xD;
          -  ECOG Performance status &lt; 2.&#xD;
&#xD;
          -  Women of child-bearing potential must agree to use adequate contraception (hormonal or&#xD;
             barrier method of birth control, abstinence) prior to study entry and for the duration&#xD;
             of study participation. Should a woman become pregnant or suspect she is pregnant&#xD;
             while participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          -  Signed written informed consent (approved by an Independent Ethics Committee) obtained&#xD;
             prior to any study specific baseline procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decompensated cirrhosis (Child Pugh B, C).&#xD;
&#xD;
          -  Extra-hepatic tumour spread.&#xD;
&#xD;
          -  Previous or concomitant malignancies within five years other than basal cell carcinoma&#xD;
             of the skin.&#xD;
&#xD;
          -  Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or&#xD;
             barrier method of birth control, abstinence).&#xD;
&#xD;
          -  Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or&#xD;
             tuberculosis, sclerosing cholangitis, …).&#xD;
&#xD;
          -  Previous trans-arterial radioembolization (TARE).&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition of the administered materials.&#xD;
&#xD;
          -  Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular&#xD;
             incident within the last six months.&#xD;
&#xD;
          -  Major surgery within four weeks.&#xD;
&#xD;
          -  Uncontrolled concurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Uncontrolled Diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alain Hendlisz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jules Bordet Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vincent Donckier, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasme University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasme Hosptial</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.bordet.be/</url>
    <description>Jules Bordet Institute</description>
  </link>
  <link>
    <url>http://www.erasme.ulb.ac.be/</url>
    <description>Erasme Hospital</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>June 30, 2015</last_update_submitted>
  <last_update_submitted_qc>June 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Liver Cirrhosis</keyword>
  <keyword>radioembolization</keyword>
  <keyword>SIRT</keyword>
  <keyword>TARE</keyword>
  <keyword>Sirspheres</keyword>
  <keyword>neoadjuvant</keyword>
  <keyword>liver cancer</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>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT01686880
org study id: TRYPHON
nct id: NCT01686880
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety of transarterial radioembolization prior to
      surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma
The purpose of this study is to assess the peri-operative morbidity and mortality of
      supraselective ablative transarterial radioembolization prior to surgical resection or
      radiofrequency in cirrhotic patients with HCC
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peri-operative morbidity
time frame: 3 months after surgery
description: peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)
measure: Survival
time frame: 3 years
description: Assessment of the overall disease free survival and Overall Survival
measure: One and three years survival
time frame: one and three years
description: Estimation of disease free survival and overall survival rates after 1 and 3 years
measure: Tumor regression
time frame: 8 weeks after Trans-arterial radioembolization
description: Assessment of tumour size regression after Trans-arterial radioembolization by MRI
measure: Functional Imaging
time frame: 3 years
description: Assessment of imaging parameters changes (DW-MRI, FDG-PET/CT) and MAA-SPECT-CT in relation to the outcome measured by tumour regression after TARE, disease free and overall survival.
measure: Contra-lateral Lobe Hypertrophy
time frame: 3 Years
description: Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI).
arm group label: Preoperative aTARE
arm group type: Experimental
description: The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery
intervention type: Device
intervention name: Sirsphere trans-arterial radioembolization
description: Patients will receive Sirsphere trans-arterial radioembolization before surgery
arm group label: Preoperative aTARE
other name: TARE
other name: SIRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alain Hendlisz, MD
role: Principal Investigator
affiliation: Jules Bordet Institute
last name: Vincent Donckier, MD, PHD
role: Principal Investigator
affiliation: Erasme University Hospital
facility: 
facility: 
country: Belgium
url: http://www.bordet.be/
description: Jules Bordet Institute
url: http://www.erasme.ulb.ac.be/
description: Erasme Hospital
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Cirrhosis
mesh term: Fibrosis