<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/NCT03286738</url>
  </required_header>
  <id_info>
    <org_study_id>CTP_401</org_study_id>
    <nct_id>NCT03286738</nct_id>
  </id_info>
  <brief_title>Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regimen as First-line Treatment in Metastatic Colorectal Cancer</brief_title>
  <official_title>Pattern of Use of Bevacizumab or Cetuximab in Patients With Metastatic Colorectal Cancer When Added to FOLFIRI Regimen as First-line Treatment; Multicenter, Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joong Bae Ahn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Registry&#xD;
&#xD;
        -  Multicenter, prospective observational study&#xD;
&#xD;
        -  Observe adverse events and efficacy in recruited patients for 3 years under real world&#xD;
           settings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>percentage of use FOLFIRI regimen and target agents</measure>
    <time_frame>through study completion, 3 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRI, target agent</intervention_name>
    <description>Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab&#xD;
Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        hemato oncology clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients at least 19 years of age with metastatic colorectal cancer who are&#xD;
             planned to receive Bevacizumab or Cetuximab in combination with FOLFIRI regimen as&#xD;
             first-line treatment&#xD;
&#xD;
          2. Patients who will receive irinotecan, a component of FOLFIRI regimen, using Camtop&#xD;
             Injection®&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Patients with conditions in which any study drug is contraindicated per the respective&#xD;
        approved label.&#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>Joong Bae Ahn</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital, YUHS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joong Bae Ahn</last_name>
    <phone>82-2-2228-8134</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei University Health System, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joong Bae Ahn, MD,PhD</last_name>
      <phone>82-2-2228-8134</phone>
      <email>vvswm513@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Joong Bae Ahn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT03286738
org study id: CTP_401
nct id: NCT03286738
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  Registry

        -  Multicenter, prospective observational study

        -  Observe adverse events and efficacy in recruited patients for 3 years under real world
           settings.
observational model: Case-Only
time perspective: Prospective
measure: percentage of use FOLFIRI regimen and target agents
time frame: through study completion, 3 years
intervention type: Drug
intervention name: FOLFIRI, target agent
description: Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab
Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Joong Bae Ahn
role: Principal Investigator
affiliation: Severance Hospital, YUHS
last name: Joong Bae Ahn
phone: 82-2-2228-8134
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Yonsei University
investigator full name: Joong Bae Ahn
investigator title: Professor
mesh term: Colorectal Neoplasms