<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/NCT04456621</url>
  </required_header>
  <id_info>
    <org_study_id>2018-10-048</org_study_id>
    <nct_id>NCT04456621</nct_id>
  </id_info>
  <brief_title>Proton Beam Therapy for Unresectable Liver Metasatsis</brief_title>
  <official_title>Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators performed the present study to evaluate the role of proton beam therapy for&#xD;
      liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in&#xD;
      terms of local control and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 month local control rate</measure>
    <time_frame>at the point of 6 month follow-up after PBT</time_frame>
    <description>local control rate (except local progression)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>at the point of 2 year follow-up after PBT</time_frame>
    <description>overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 month side effect</measure>
    <time_frame>at the point of 6 month follow-up after PBT</time_frame>
    <description>side effect</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Local Control Rate</condition>
  <condition>Side Effect</condition>
  <arm_group>
    <arm_group_label>PBT arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PBT</intervention_name>
    <description>Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx</description>
    <arm_group_label>PBT arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathologically diagnosed cancer patient&#xD;
&#xD;
          -  confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging&#xD;
             (MRI) or biopsy&#xD;
&#xD;
          -  unresectable or unsuitable for RFA&#xD;
&#xD;
          -  solitary liver metastasis or less than 3 metastatic lesions if the distance is less&#xD;
             than 3 cm between metastatic lesions&#xD;
&#xD;
          -  case discussed by surgeon, radiologist, and radiation oncologist&#xD;
&#xD;
          -  Eastern cooperative oncology group performance status 0 to 2&#xD;
&#xD;
          -  optimal liver and renal function (Child-Pugh score 10 or less)&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  agree to be contraceptive for the duration of the study and for the next 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled ascites or hepatorenal syndrome&#xD;
&#xD;
          -  status of pregnancy or breast-feeding&#xD;
&#xD;
          -  less than 12 weeks of expected survival&#xD;
&#xD;
          -  combined disease known to have high radiation side effects&#xD;
&#xD;
          -  serious acute illness that is not treated other than liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hee Chul Park, M.D., Ph.D.</last_name>
      <phone>82-2-3410-2612</phone>
      <email>hee.ro.park@samsung.com</email>
    </contact>
    <investigator>
      <last_name>Hee Chul Park, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeong Il Yu, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Do Hoon Lim, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jae Myoung Noh, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Park Hee Chul</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04456621
org study id: 2018-10-048
nct id: NCT04456621
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators performed the present study to evaluate the role of proton beam therapy for
      liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in
      terms of local control and safety.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE
primary purpose: Treatment
masking: None (Open Label)
measure: 6 month local control rate
time frame: at the point of 6 month follow-up after PBT
description: local control rate (except local progression)
measure: Overall survival rate
time frame: at the point of 2 year follow-up after PBT
description: overall survival rate
measure: 6 month side effect
time frame: at the point of 6 month follow-up after PBT
description: side effect
arm group label: PBT arm
arm group type: Experimental
intervention type: Radiation
intervention name: PBT
description: Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx
arm group label: PBT arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Park Hee Chul
investigator title: Professor
sharing ipd: Undecided