<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/NCT01676922</url>
  </required_header>
  <id_info>
    <org_study_id>ML27768</org_study_id>
    <nct_id>NCT01676922</nct_id>
  </id_info>
  <brief_title>An Observational Study of Avastin and Conventional Chemotherapy in Patients &gt;/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)</brief_title>
  <official_title>Prospective Non-interventional Study to Collect Data on the Use of Avastin and Conventional Chemotherapy for the Treatment of Previously Untreated Metastatic Colorectal Cancer in Patients &gt;/= 70 Years</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 observational study will evaluate the use of Avastin (bevacizumab) and conventional&#xD;
      chemotherapy in patients &gt;/= 70 years of age with previously untreated metastatic colorectal&#xD;
      cancer. Data will be collected from each patient from initiation of treatment until disease&#xD;
      progression occurs (minimum follow-up 12 months).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice</measure>
    <time_frame>approximately 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice</measure>
    <time_frame>approximately 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events/adverse events of special interest</measure>
    <time_frame>approximately 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical/demographic patient characteristics at baseline</measure>
    <time_frame>approximately 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage/regimen</measure>
    <time_frame>approximately 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment</measure>
    <time_frame>approximately 24 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">256</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients &gt;/= 70 years of age with previously untreated metastatic colorectal cancer&#xD;
        suitable to receive chemotherapy with or without Avastin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/ 70 years of age&#xD;
&#xD;
          -  Previously untreated metastatic colorectal cancer&#xD;
&#xD;
          -  Patient considered suitable to receive chemotherapy with or without Avastin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any other clinical trial or study with the exception of participation&#xD;
             in registries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 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>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Assebroek</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bornem</city>
        <zip>2880</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brasschaat</city>
        <zip>2930</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haine-Saint-Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hornu</city>
        <zip>7301</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ieper</city>
        <zip>8900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lier</city>
        <zip>2500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mechelen</city>
        <zip>2800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mont-godinne</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oostende</city>
        <zip>8400</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oudenaarde</city>
        <zip>9700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ronse</city>
        <zip>9600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seraing</city>
        <zip>4100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tongeren</city>
        <zip>3700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Verviers</city>
        <zip>4800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <removed_countries>
    <country>Russian Federation</country>
  </removed_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 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>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/NCT01676922
org study id: ML27768
nct id: NCT01676922
lead sponsor: 
This observational study will evaluate the use of Avastin (bevacizumab) and conventional
      chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal
      cancer. Data will be collected from each patient from initiation of treatment until disease
      progression occurs (minimum follow-up 12 months).
observational model: Cohort
time perspective: Prospective
measure: Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice
time frame: approximately 24 months
measure: Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice
time frame: approximately 24 months
measure: Safety: Incidence of adverse events/adverse events of special interest
time frame: approximately 24 months
measure: Clinical/demographic patient characteristics at baseline
time frame: approximately 24 months
measure: Dosage/regimen
time frame: approximately 24 months
measure: Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment
time frame: approximately 24 months
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Belgium
country: Russian Federation
responsible party type: Sponsor
mesh term: Colorectal Neoplasms