<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/NCT04466124</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2018-0197</org_study_id>
    <nct_id>NCT04466124</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy</brief_title>
  <official_title>Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Liver Cancer Patients Treated With Proton Beam Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</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>
      Liver cancer is the fourth most common malignant tumor in Korea and it is the third most&#xD;
      common cause of cancer death worldwide according to the 2009 Korea Central Cancer&#xD;
      Registration Annual Report. Excellent survival rate (50-70% 5-year survival rate) can be&#xD;
      obtained when surgery is performed including liver transplantation, but most (70-80%)&#xD;
      patients with liver cancer are difficult to get surgery due to liver disease associated with&#xD;
      cirrhosis. In addition, due to the multi-centric nature of liver cancer in patients with&#xD;
      cirrhosis, repeated treatment is required. For these reasons, various treatments for liver&#xD;
      cancer (percutaneous arterial embolization, percutaneous ethanol injection, radiofrequency&#xD;
      heat therapy, and radiation therapy) have been performed.&#xD;
&#xD;
      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising&#xD;
      treatment for liver cancer because it maximizes radiation to tumor tissues and reduces&#xD;
      radiation doses from surrounding normal tissues due to the distinct physical properties of&#xD;
      proton beams. Promising therapeutic results and less toxicity have been reported in liver&#xD;
      cancer. In addition, several genes in liver cancer (SOCS-1, GSTP, APC, VEGF, PD-EGF, HIF-1,&#xD;
      NOS, b-FGF, LINE-1, p27, TOP2A, Ets-1, Bcl-xL, Osteopontin, CD44, etc.) have been reported to&#xD;
      be associated with recurrence and prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver cancer is the fourth most common malignant tumor in Korea and it is the third most&#xD;
      common cause of cancer death worldwide according to the 2009 Korea Central Cancer&#xD;
      Registration Annual Report. Excellent survival rate (50-70% 5-year survival rate) can be&#xD;
      obtained when surgery is performed including liver transplantation, but most (70-80%)&#xD;
      patients with liver cancer are difficult to get surgery due to liver disease associated with&#xD;
      cirrhosis. In addition, due to the multi-centric nature of liver cancer in patients with&#xD;
      cirrhosis, repeated treatment is required. For these reasons, various treatments for liver&#xD;
      cancer (percutaneous arterial embolization, percutaneous ethanol injection, radiofrequency&#xD;
      heat therapy, and radiation therapy) have been performed.&#xD;
&#xD;
      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising&#xD;
      treatment for liver cancer because it maximizes radiation to tumor tissues and reduces&#xD;
      radiation doses from surrounding normal tissues due to the distinct physical properties of&#xD;
      proton beams. Promising therapeutic results and less toxicity have been reported in liver&#xD;
      cancer. In addition, several genes in liver cancer (SOCS-1, GSTP, APC, VEGF, PD-EGF, HIF-1,&#xD;
      NOS, b-FGF, LINE-1, p27, TOP2A, Ets-1, Bcl-xL, Osteopontin, CD44, etc.) have been reported to&#xD;
      be associated with recurrence and prognosis. Therefore, in this study, the investigator is&#xD;
      going to establish a prospective cohort of liver cancer patients treated with proton beam&#xD;
      therapy. It be used for analyzing local control, survival, recurrence, toxicity, proton&#xD;
      treatment plan information, gene expression information, then local control (LC), overall&#xD;
      survival. (overall survival, OS), recurrence-free surival (RFS), and factors that predict&#xD;
      treatment-related toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2028</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Establish a cohort of liver cancer patients treadted with proton beam therapy.</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>The primary outcome is to establish a prospective cohort of liver cancer patients treadted with proton beam therapy. It is for exploration of factors and models that predict local control, recurrence, survival and treatment-related toxicity in liver cancer patients undergoing proton therapy.</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Liver Cancer</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Liver Cancer Patients Treated With Proton Beam Therapy</intervention_name>
    <description>Proton Beam Therapy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Liver cancer patients over the age of 19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver cancer patients scheduled to be proton beam therapy&#xD;
&#xD;
          -  Agreed to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Disagreed to participate in this study&#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>Tae Hyun Kim, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center Korea</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi</state>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Tae Hyun Kim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Proton Beam Therapy</keyword>
  <keyword>Cohort Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT04466124
org study id: NCC2018-0197
nct id: NCT04466124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Liver cancer is the fourth most common malignant tumor in Korea and it is the third most
      common cause of cancer death worldwide according to the 2009 Korea Central Cancer
      Registration Annual Report. Excellent survival rate (50-70% 5-year survival rate) can be
      obtained when surgery is performed including liver transplantation, but most (70-80%)
      patients with liver cancer are difficult to get surgery due to liver disease associated with
      cirrhosis. In addition, due to the multi-centric nature of liver cancer in patients with
      cirrhosis, repeated treatment is required. For these reasons, various treatments for liver
      cancer (percutaneous arterial embolization, percutaneous ethanol injection, radiofrequency
      heat therapy, and radiation therapy) have been performed.

      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising
      treatment for liver cancer because it maximizes radiation to tumor tissues and reduces
      radiation doses from surrounding normal tissues due to the distinct physical properties of
      proton beams. Promising therapeutic results and less toxicity have been reported in liver
      cancer. In addition, several genes in liver cancer (SOCS-1, GSTP, APC, VEGF, PD-EGF, HIF-1,
      NOS, b-FGF, LINE-1, p27, TOP2A, Ets-1, Bcl-xL, Osteopontin, CD44, etc.) have been reported to
      be associated with recurrence and prognosis.
Liver cancer is the fourth most common malignant tumor in Korea and it is the third most
      common cause of cancer death worldwide according to the 2009 Korea Central Cancer
      Registration Annual Report. Excellent survival rate (50-70% 5-year survival rate) can be
      obtained when surgery is performed including liver transplantation, but most (70-80%)
      patients with liver cancer are difficult to get surgery due to liver disease associated with
      cirrhosis. In addition, due to the multi-centric nature of liver cancer in patients with
      cirrhosis, repeated treatment is required. For these reasons, various treatments for liver
      cancer (percutaneous arterial embolization, percutaneous ethanol injection, radiofrequency
      heat therapy, and radiation therapy) have been performed.

      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising
      treatment for liver cancer because it maximizes radiation to tumor tissues and reduces
      radiation doses from surrounding normal tissues due to the distinct physical properties of
      proton beams. Promising therapeutic results and less toxicity have been reported in liver
      cancer. In addition, several genes in liver cancer (SOCS-1, GSTP, APC, VEGF, PD-EGF, HIF-1,
      NOS, b-FGF, LINE-1, p27, TOP2A, Ets-1, Bcl-xL, Osteopontin, CD44, etc.) have been reported to
      be associated with recurrence and prognosis. Therefore, in this study, the investigator is
      going to establish a prospective cohort of liver cancer patients treated with proton beam
      therapy. It be used for analyzing local control, survival, recurrence, toxicity, proton
      treatment plan information, gene expression information, then local control (LC), overall
      survival. (overall survival, OS), recurrence-free surival (RFS), and factors that predict
      treatment-related toxicity.
observational model: Cohort
time perspective: Prospective
measure: Establish a cohort of liver cancer patients treadted with proton beam therapy.
time frame: Up to 10 years
description: The primary outcome is to establish a prospective cohort of liver cancer patients treadted with proton beam therapy. It is for exploration of factors and models that predict local control, recurrence, survival and treatment-related toxicity in liver cancer patients undergoing proton therapy.
intervention type: Radiation
intervention name: Liver Cancer Patients Treated With Proton Beam Therapy
description: Proton Beam Therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Tae Hyun Kim, Ph.D
role: Principal Investigator
affiliation: National Cancer Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Tae Hyun Kim
investigator title: Principal Investigator
mesh term: Liver Neoplasms