<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/NCT03829852</url>
  </required_header>
  <id_info>
    <org_study_id>2018-12-013BC</org_study_id>
    <nct_id>NCT03829852</nct_id>
  </id_info>
  <brief_title>Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients</brief_title>
  <official_title>Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Koo Foundation Sun Yat-Sen Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</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>
      Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies&#xD;
      of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days&#xD;
      off) and 160 mg dose given once daily.&#xD;
&#xD;
      In the clinic, patients often have some complicated condition. This study aims to perform&#xD;
      retrospective medical chart review of mCRC patients who received regorafenib treatment in two&#xD;
      medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">December 8, 2020</completion_date>
  <primary_completion_date type="Actual">December 8, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of regorafenib use in routine clinical practice setting, assessed by initial dose</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eligibility of subsequent therapies and the outcome, assessed by type of treatment (anti-epithelial growth factor receptor [EGFR], anti-vascular endothelial growth factor [VEGF], and/or chemotherapy agents)</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eligibility of subsequent therapies and the outcome, assessed by treatment duration</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eligibility of subsequent therapies and the outcome, assessed by PFS</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by patient characteristics</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>correlation</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carcinoembryonic antigen (CEA) levels</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>correlation</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carbohydrate antigen (CA19-9) levels</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>correlation</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory outcome: Image pattern as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in image patterns</measure>
    <time_frame>through study completion, estimated 2 years</time_frame>
    <description>correlation</description>
  </other_outcome>
  <enrollment type="Actual">716</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Regorafenib</intervention_name>
    <description>Treatment was performed based on physician's discretion</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        mCRC patients who received regorafenib treatment in Taipei Veterans General Hospital and&#xD;
        Chang Gung Memorial Hospital Linkou, Taiwan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mCRC patients who received at least one dose of regorafenib treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;=20 y/o&#xD;
&#xD;
          -  Patients who did not receive regorafenib treatment will be excluded from the analysis&#xD;
&#xD;
          -  Patients with incomplete medical records that are deemed ineligible for analysis by&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hao-Wei Teng, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</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>
  <!-- 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/NCT03829852
org study id: 2018-12-013BC
nct id: NCT03829852
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies
      of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days
      off) and 160 mg dose given once daily.

      In the clinic, patients often have some complicated condition. This study aims to perform
      retrospective medical chart review of mCRC patients who received regorafenib treatment in two
      medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice
      setting.
observational model: Cohort
time perspective: Retrospective
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)
time frame: through study completion, estimated 2 years
description: months
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)
time frame: through study completion, estimated 2 years
description: months
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)
time frame: through study completion, estimated 2 years
description: months
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response
time frame: through study completion, estimated 2 years
description: percentage
measure: Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)
time frame: through study completion, estimated 2 years
description: percentage
measure: Safety of regorafenib use in routine clinical practice setting, assessed by initial dose
time frame: through study completion, estimated 2 years
description: percentage
measure: Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles
time frame: through study completion, estimated 2 years
description: percentage
measure: Eligibility of subsequent therapies and the outcome, assessed by type of treatment (anti-epithelial growth factor receptor [EGFR], anti-vascular endothelial growth factor [VEGF], and/or chemotherapy agents)
time frame: through study completion, estimated 2 years
description: percentage
measure: Eligibility of subsequent therapies and the outcome, assessed by treatment duration
time frame: through study completion, estimated 2 years
description: months
measure: Eligibility of subsequent therapies and the outcome, assessed by PFS
time frame: through study completion, estimated 2 years
description: months
measure: Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by patient characteristics
time frame: through study completion, estimated 2 years
description: correlation
measure: Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carcinoembryonic antigen (CEA) levels
time frame: through study completion, estimated 2 years
description: correlation
measure: Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carbohydrate antigen (CA19-9) levels
time frame: through study completion, estimated 2 years
description: correlation
measure: Exploratory outcome: Image pattern as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in image patterns
time frame: through study completion, estimated 2 years
description: correlation
intervention type: Drug
intervention name: Regorafenib
description: Treatment was performed based on physician's discretion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hao-Wei Teng, MD, PhD
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Colorectal Neoplasms