<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/NCT01664494</url>
  </required_header>
  <id_info>
    <org_study_id>ML25281</org_study_id>
    <nct_id>NCT01664494</nct_id>
  </id_info>
  <brief_title>An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer</brief_title>
  <official_title>A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast 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 multi-center observational study will evaluate the use of Xeloda (capecitabine) in&#xD;
      patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced&#xD;
      gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving&#xD;
      treatment with Xeloda according to product label will be followed for up to 10 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment</measure>
    <time_frame>Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first</time_frame>
    <description>Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Dose of Capecitabine</measure>
    <time_frame>Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first</time_frame>
    <description>Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">563</enrollment>
  <condition>Breast Cancer, Colorectal Cancer, Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Capecitabine</arm_group_label>
    <description>Participants will receive capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine will be given according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
    <arm_group_label>Capecitabine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced&#xD;
        gastric cancer or breast cancer receiving Xeloda&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting,&#xD;
             advanced gastric cancer or breast cancer who are candidates for receiving Xeloda&#xD;
             according to product label&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications according to label and off-label use&#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>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>November 19, 2015</results_first_submitted>
  <results_first_submitted_qc>March 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 2, 2016</results_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 2, 2016</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>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.</recruitment_details>
      <pre_assignment_details>Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Capecitabine</title>
          <description>Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="563"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="370"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="193"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Capecitabine</title>
          <description>Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="563"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.0" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">The gender was not assessed in this study.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">The gender was not assessed in this study.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment</title>
        <description>Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.</description>
        <time_frame>Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first</time_frame>
        <population>All enrolled participants were considered for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine</title>
            <description>Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment</title>
          <description>Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.</description>
          <population>All enrolled participants were considered for this outcome measure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="563"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjuvant therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>First line therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second line therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third line therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Dose of Capecitabine</title>
        <description>Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.</description>
        <time_frame>Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first</time_frame>
        <population>All enrolled participants were considered for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Capecitabine</title>
            <description>Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Dose of Capecitabine</title>
          <description>Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.</description>
          <population>All enrolled participants were considered for this outcome measure.</population>
          <units>Milligrams</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="563"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3500" lower_limit="1500" upper_limit="5000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>From Month 8 onwards</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3000" lower_limit="900" upper_limit="5000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first</time_frame>
      <desc>SAEs and other AEs were collected in all enrolled participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Capecitabine</title>
          <description>Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Multiple Organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Inflammatory marker increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="271" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="117" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="110" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="563"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="172" subjects_at_risk="563"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>1-800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01664494
org study id: ML25281
nct id: NCT01664494
lead sponsor: 
This multi-center observational study will evaluate the use of Xeloda (capecitabine) in
      patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced
      gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving
      treatment with Xeloda according to product label will be followed for up to 10 months.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment
time frame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
description: Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.
measure: Median Dose of Capecitabine
time frame: Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
description: Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.
arm group label: Capecitabine
description: Participants will receive capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine will be given according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
arm group label: Capecitabine
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: 
country: Austria
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Stomach Neoplasms
mesh term: Capecitabine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 