<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/NCT01712347</url>
  </required_header>
  <id_info>
    <org_study_id>ML28233</org_study_id>
    <nct_id>NCT01712347</nct_id>
  </id_info>
  <brief_title>An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer</brief_title>
  <official_title>An Open-Label, Multicenter, Non-Interventional, Observational Study To Assess The Effect Of First Line Bevacizumab Treatment With Fluoropyrimidine-Based Chemotherapy (CTX) In Patients With Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multicenter observational study will evaluate the efficacy and safety of first-line&#xD;
      bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants&#xD;
      with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has&#xD;
      decided to initiate first-line fluoropyrimidine based chemotherapy in combination with&#xD;
      bevacizumab will be observed for approximately 4 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2012</start_date>
  <completion_date type="Actual">July 1, 2016</completion_date>
  <primary_completion_date type="Actual">July 1, 2016</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>Overall survival from the time of starting first-line therapy</measure>
    <time_frame>Start of first line therapy until death (up to approximately 4 years)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria</measure>
    <time_frame>Start of first line therapy until death (up to approximately 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria</measure>
    <time_frame>Start of first line therapy until death (up to approximately 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with liver resection</measure>
    <time_frame>up to approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to approximately 4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">351</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>mCRC Participants</arm_group_label>
    <description>mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab will be administered as per approved label.</description>
    <arm_group_label>mCRC Participants</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.</description>
    <arm_group_label>mCRC Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with metastatic colorectal cancer receiving first-line bevacizumab in&#xD;
        combination with fluoropyrimidine-based chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with histologically confirmed metastatic colorectal cancer who will&#xD;
             receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants not qualified for bevacizumab treatment according to the local label&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Chai Yi; Surgery</name>
      <address>
        <city>Chai Yi</city>
        <zip>613</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery</name>
      <address>
        <city>Kaohsiung</city>
        <zip>00833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital; Dept of Surgery</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung Uni Hospital; Dept of Hematology and Oncology</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans General Hospital; Division of Oncology</name>
      <address>
        <city>Taipei</city>
        <zip>00112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital; Hematology and Oncology</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
  </intervention_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/NCT01712347
org study id: ML28233
nct id: NCT01712347
lead sponsor: 
This multicenter observational study will evaluate the efficacy and safety of first-line
      bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants
      with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has
      decided to initiate first-line fluoropyrimidine based chemotherapy in combination with
      bevacizumab will be observed for approximately 4 years.
observational model: Cohort
time perspective: Prospective
measure: Overall survival from the time of starting first-line therapy
time frame: Start of first line therapy until death (up to approximately 4 years)
measure: Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
time frame: Start of first line therapy until death (up to approximately 4 years)
measure: Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria
time frame: Start of first line therapy until death (up to approximately 4 years)
measure: Percentage of participants with liver resection
time frame: up to approximately 4 years
measure: Number of participants with adverse events
time frame: up to approximately 4 years
arm group label: mCRC Participants
description: mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab will be administered as per approved label.
arm group label: mCRC Participants
other name: Avastin
intervention type: Drug
intervention name: Chemotherapy
description: The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
arm group label: mCRC Participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Bevacizumab