<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/NCT04466189</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2018-0198</org_study_id>
    <nct_id>NCT04466189</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy</brief_title>
  <official_title>Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Pancreatic 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>
      Pancreatic cancer is one of the few cancers whose survival rate has not improved&#xD;
      significantly due to high local recurrence and systemic metastasis despite advances in&#xD;
      diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth&#xD;
      leading cause of cancer-related death in Korea. For this reason, various anti-cancer&#xD;
      therapies and radiotherapy have been tested to improve survival.&#xD;
&#xD;
      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising&#xD;
      treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal&#xD;
      tissue while maximizing radiation to tumor tissues due to the distinct physical properties of&#xD;
      proton beam. Low toxicity have been reported. In addition, retrospective analysis of&#xD;
      pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July&#xD;
      2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months;&#xD;
      Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1,&#xD;
      MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been&#xD;
      reported to be associated with recurrence and prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic cancer is one of the few cancers whose survival rate has not improved&#xD;
      significantly due to high local recurrence and systemic metastasis despite advances in&#xD;
      diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth&#xD;
      leading cause of cancer-related death in Korea. For this reason, various anti-cancer&#xD;
      therapies and radiotherapy have been tested to improve survival.&#xD;
&#xD;
      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising&#xD;
      treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal&#xD;
      tissue while maximizing radiation to tumor tissues due to the distinct physical properties of&#xD;
      proton beam. Low toxicity have been reported. In addition, retrospective analysis of&#xD;
      pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July&#xD;
      2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months;&#xD;
      Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1,&#xD;
      MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been&#xD;
      reported to be associated with recurrence and prognosis. Therefore, in this study, a&#xD;
      prospective cohort of pancreatic cancer patients treated with proton beam therapy was&#xD;
      established to analyze local control, survival, recurrence, toxicity, proton treatment plan&#xD;
      information, gene expression information to analyze local control (LC), overall survival&#xD;
      (OS), recurrence-free surival (RFS), and factors predicting 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 Pancreatic 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 pancreatic cancer patients treadted with proton beam therapy. It is for exploring factors and models that predict local control, relapse, survival and treatment-related toxicity in patients with pancreatic cancer who have undergone proton therapy.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pancreas Cancer</condition>
  <arm_group>
    <arm_group_label>Pancreatic Cancer Patients Treated With Proton Beam Therapy</arm_group_label>
    <description>Pancreatic Cancer Patients Treated With Proton Beam Therapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pancreatic cancer patients over the age of 19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pancreatic 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>
  </eligibility>
  <overall_official>
    <last_name>Tae Hyun Kim</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 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 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>Pancreatic 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/NCT04466189
org study id: NCC2018-0198
nct id: NCT04466189
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pancreatic cancer is one of the few cancers whose survival rate has not improved
      significantly due to high local recurrence and systemic metastasis despite advances in
      diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth
      leading cause of cancer-related death in Korea. For this reason, various anti-cancer
      therapies and radiotherapy have been tested to improve survival.

      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising
      treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal
      tissue while maximizing radiation to tumor tissues due to the distinct physical properties of
      proton beam. Low toxicity have been reported. In addition, retrospective analysis of
      pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July
      2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months;
      Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1,
      MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been
      reported to be associated with recurrence and prognosis.
Pancreatic cancer is one of the few cancers whose survival rate has not improved
      significantly due to high local recurrence and systemic metastasis despite advances in
      diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth
      leading cause of cancer-related death in Korea. For this reason, various anti-cancer
      therapies and radiotherapy have been tested to improve survival.

      Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising
      treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal
      tissue while maximizing radiation to tumor tissues due to the distinct physical properties of
      proton beam. Low toxicity have been reported. In addition, retrospective analysis of
      pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July
      2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months;
      Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1,
      MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been
      reported to be associated with recurrence and prognosis. Therefore, in this study, a
      prospective cohort of pancreatic cancer patients treated with proton beam therapy was
      established to analyze local control, survival, recurrence, toxicity, proton treatment plan
      information, gene expression information to analyze local control (LC), overall survival
      (OS), recurrence-free surival (RFS), and factors predicting treatment-related toxicity.
observational model: Cohort
time perspective: Prospective
measure: Establish a cohort of Pancreatic cancer patients treadted with proton beam therapy.
time frame: Up to 10 years
description: The primary outcome is to establish a prospective cohort of pancreatic cancer patients treadted with proton beam therapy. It is for exploring factors and models that predict local control, relapse, survival and treatment-related toxicity in patients with pancreatic cancer who have undergone proton therapy.
arm group label: Pancreatic Cancer Patients Treated With Proton Beam Therapy
description: Pancreatic Cancer Patients Treated With Proton Beam Therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
last name: Tae Hyun Kim
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: Pancreatic Neoplasms