xml: <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/NCT06029010</url>
    </required_header>
    <id_info>
      <org_study_id>22624</org_study_id>
      <nct_id>NCT06029010</nct_id>
    </id_info>
    <brief_title>An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States</brief_title>
    <acronym>COLONGER</acronym>
    <official_title>Real-world Study in Metastatic Colorectal Cancer Patients With Long-term Responses to Regorafenib in the US</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bayer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bayer</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>
        This is an observational study in which data already collected from patients with metastatic&#xD;
        colorectal cancer will be studied.&#xD;
  &#xD;
        Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum&#xD;
        (lowest part of the bowel just before the anus) that has spread to other parts of the body.&#xD;
  &#xD;
        The study drug, regorafenib, is already approved for cancer doctors to prescribe to patients&#xD;
        with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are&#xD;
        involved in the growth of cancer.&#xD;
  &#xD;
        The participants in this study were treated with regorafenib as part of their regular care&#xD;
        from their doctors.&#xD;
  &#xD;
        Some studies have shown that patients with mCRC who took regorafenib had improved survival&#xD;
        outcomes, and some of them did well on the treatment for a long time. Cancer doctors have&#xD;
        also reported from their routine practice that some patients with mCRC are able to respond to&#xD;
        regorafenib for a longer period than others. However, there is limited knowledge about which&#xD;
        people this is likely to happen for.&#xD;
  &#xD;
        To better understand the long-term response of regorafenib treatment, there is a need for a&#xD;
        large-scale study in the real world.&#xD;
  &#xD;
        The main purpose of this study is to learn more about patients who showed a long-term&#xD;
        response to regorafenib as a mono treatment for mCRC. To do this, researchers will collect&#xD;
        the following information from the participants' health records:&#xD;
  &#xD;
        Duration of treatment with regorafenib&#xD;
  &#xD;
        Percentage of participants who received treatment with regorafenib for at least 5 months and&#xD;
        4 months.&#xD;
  &#xD;
        Characteristics, including age, sex, race, health condition, and signs and symptoms of mCRC,&#xD;
        of participants who received treatment with regorafenib for at least 5 months and 4 months.&#xD;
  &#xD;
        The data will come from an electronic health records database called the Flatiron Health Data&#xD;
        Repository for patients in the United States. The data will be from patients with mCRC who&#xD;
        started treatment with regorafenib between July 2013 and December 2022.&#xD;
  &#xD;
        Researchers will consider the data of the participants collected until May 2023.&#xD;
  &#xD;
        In this study, only available data from routine care are collected. No visits or tests are&#xD;
        required as part of this study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months</measure>
      <time_frame>Retrospective analysis from 01-Jan-2013 to 31-May-2023</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2448</enrollment>
    <condition>Metastatic Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>Long-term responders of regorafenib ≥5 months</arm_group_label>
      <description>Defined as treatment duration ≥5 months after treatment initiation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Long-term responders of regorafenib ≥4 months</arm_group_label>
      <description>Defined as treatment duration ≥4 months after treatment initiation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Regorafenib (Stivarga, BAY73-4506)</intervention_name>
      <description>Follow clinical administration.</description>
      <arm_group_label>Long-term responders of regorafenib ≥4 months</arm_group_label>
      <arm_group_label>Long-term responders of regorafenib ≥5 months</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Data for the study will be obtained from the Flatiron Health Data Repository; an electronic&#xD;
          health record (EHR)-derived longitudinal demographically and geographically diverse&#xD;
          database of oncology patients in routine clinical practice in the US.&#xD;
  &#xD;
          Patients with mCRC who initiated regorafenib treatment between 1 JUL 2013 and 31 DEC 2022&#xD;
          will be followed through the electronic data from the start of regorafenib treatment until&#xD;
          the date of death for patients who died, and the date of last visit on or up to 31 MAY 2023&#xD;
          for patients with no record of death.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a diagnosis of mCRC between 1 JAN 2013 and 31 DEC 2022 who initiated&#xD;
               regorafenib monotherapy up to 14 days prior or after mCRC diagnosis and during the&#xD;
               patient selection period (1 JUL 2013 to 31 DEC 2022).&#xD;
  &#xD;
            -  Adult patients (≥18 years old) at index date (date of first regorafenib treatment).&#xD;
  &#xD;
            -  Patients with at least one recorded visit, laboratory test, or other recorded&#xD;
               electronic medical record (EMR) entry (e.g., treatment) in the Flatiron network at&#xD;
               least 3 months prior to the index date, unless the patient was diagnosed with mCRC&#xD;
               within the last 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had a diagnosis or recorded history of gastrointestinal stromal tumor&#xD;
               (GISC), hepatocellular cancer (HCC), or other primary cancers (except non-melanoma&#xD;
               skin cancers) during the 6-month period on or prior to the index date.&#xD;
  &#xD;
            -  For analyses of long-term responders, patients will be excluded if treatment duration&#xD;
               &lt;5 and &lt;4 months for treatment completers, or treatment duration &lt;5 and &lt;4 months at&#xD;
               last visit date for non-completers.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bayer Clinical Trials Contact</last_name>
      <phone>(+)1-888-84 22937</phone>
      <email>clinical-trials-contact@bayer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bayer</name>
        <address>
          <city>Whippany</city>
          <state>New Jersey</state>
          <zip>07981</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://clinicaltrials.bayer.com/</url>
      <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mCRC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029010
  org study id: 22624
  nct id: NCT06029010
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational study in which data already collected from patients with metastatic
        colorectal cancer will be studied.
  
        Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum
        (lowest part of the bowel just before the anus) that has spread to other parts of the body.
  
        The study drug, regorafenib, is already approved for cancer doctors to prescribe to patients
        with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are
        involved in the growth of cancer.
  
        The participants in this study were treated with regorafenib as part of their regular care
        from their doctors.
  
        Some studies have shown that patients with mCRC who took regorafenib had improved survival
        outcomes, and some of them did well on the treatment for a long time. Cancer doctors have
        also reported from their routine practice that some patients with mCRC are able to respond to
        regorafenib for a longer period than others. However, there is limited knowledge about which
        people this is likely to happen for.
  
        To better understand the long-term response of regorafenib treatment, there is a need for a
        large-scale study in the real world.
  
        The main purpose of this study is to learn more about patients who showed a long-term
        response to regorafenib as a mono treatment for mCRC. To do this, researchers will collect
        the following information from the participants' health records:
  
        Duration of treatment with regorafenib
  
        Percentage of participants who received treatment with regorafenib for at least 5 months and
        4 months.
  
        Characteristics, including age, sex, race, health condition, and signs and symptoms of mCRC,
        of participants who received treatment with regorafenib for at least 5 months and 4 months.
  
        The data will come from an electronic health records database called the Flatiron Health Data
        Repository for patients in the United States. The data will be from patients with mCRC who
        started treatment with regorafenib between July 2013 and December 2022.
  
        Researchers will consider the data of the participants collected until May 2023.
  
        In this study, only available data from routine care are collected. No visits or tests are
        required as part of this study.
  observational model: Cohort
  time perspective: Retrospective
  measure: Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  measure: Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
  time frame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
  arm group label: Long-term responders of regorafenib ≥5 months
  description: Defined as treatment duration ≥5 months after treatment initiation.
  arm group label: Long-term responders of regorafenib ≥4 months
  description: Defined as treatment duration ≥4 months after treatment initiation.
  intervention type: Drug
  intervention name: Regorafenib (Stivarga, BAY73-4506)
  description: Follow clinical administration.
  arm group label: Long-term responders of regorafenib ≥4 months
  arm group label: Long-term responders of regorafenib ≥5 months
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bayer Clinical Trials Contact
  phone: (+)1-888-84 22937
  email: clinical-trials-contact@bayer.com
  facility: 
  country: United States
  url: https://clinicaltrials.bayer.com/
  description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: No
  ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.