<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/NCT01674907</url>
  </required_header>
  <id_info>
    <org_study_id>ML22399</org_study_id>
    <nct_id>NCT01674907</nct_id>
  </id_info>
  <brief_title>An Observational Study of Avastin (Bevacizumab) in First Line in Patients With Metastatic Colorectal Cancer (AVANiS)</brief_title>
  <official_title>Non-interventional Study of Avastin in 1st Line 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 observational study will evaluate the use in clinical practice and the efficacy of&#xD;
      Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received&#xD;
      prior chemotherapy treatment in the metastatic setting. Patients for whom the treating&#xD;
      physician has decided to initiate therapy with Avastin will be followed for 10 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 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>Dosage/schedule of 1st-line Avastin</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of treatment</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Chemotherapy regimens used in clinical practice</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical/demographic patient characteristics at baseline</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between termination of Avastin treatment and time point of progression</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic colorectal cancer without prior chemotherapy in the metastatic&#xD;
        setting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Histologically confirmed metastatic colorectal cancer without prior chemotherapy in&#xD;
             the metastatic setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for Avastin according to the locally approved package insert&#xD;
             (version 7 April 2006)&#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>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>George</city>
        <zip>6529</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Elizabeth</city>
        <zip>6045</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pretoria</city>
        <zip>0001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vereeniging</city>
        <zip>1939</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 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/NCT01674907
org study id: ML22399
nct id: NCT01674907
lead sponsor: 
This observational study will evaluate the use in clinical practice and the efficacy of
      Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received
      prior chemotherapy treatment in the metastatic setting. Patients for whom the treating
      physician has decided to initiate therapy with Avastin will be followed for 10 months.
observational model: Cohort
time perspective: Prospective
measure: Dosage/schedule of 1st-line Avastin
time frame: approximately 3 years
measure: Duration of treatment
time frame: approximately 3 years
measure: Chemotherapy regimens used in clinical practice
time frame: approximately 3 years
measure: Clinical/demographic patient characteristics at baseline
time frame: approximately 3 years
measure: Progression-free survival
time frame: approximately 3 years
measure: Relationship between termination of Avastin treatment and time point of progression
time frame: approximately 3 years
arm group label: Cohort
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: 
country: South Africa
responsible party type: Sponsor
mesh term: Colorectal Neoplasms