<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/NCT02228668</url>
  </required_header>
  <id_info>
    <org_study_id>S-AVANT C13-1</org_study_id>
    <nct_id>NCT02228668</nct_id>
  </id_info>
  <brief_title>Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma</brief_title>
  <official_title>Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GERCOR - Multidisciplinary Oncology Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GERCOR - Multidisciplinary Oncology Cooperative Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up&#xD;
      of patients previously included in the AVANT trial from December 2004 to June 2007.&#xD;
&#xD;
      Clinical data of the AVANT trial will be updated. Neither additional examination nor&#xD;
      administration of any treatment will be performed on the patients.&#xD;
&#xD;
      330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium,&#xD;
      Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece,&#xD;
      Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway,&#xD;
      Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden,&#xD;
      Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).&#xD;
&#xD;
      The AVANT study aiming at demonstrating superiority of bevacizumab in combination with&#xD;
      FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when&#xD;
      adding bevacizumab to chemotherapy in resected stage III colon cancer.&#xD;
&#xD;
      Adverse events were consistent with the known safety profile of bevacizumab. However, more&#xD;
      relapses and deaths due to disease progression have been observed in both bevacizumab arms.&#xD;
&#xD;
      A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term&#xD;
      results and safety.&#xD;
&#xD;
      Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected&#xD;
      at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median&#xD;
      follow-up (expected to be reached around Q2 2016).&#xD;
&#xD;
      All analyses will be performed on an exploratory purpose only. An analysis at 8 years median&#xD;
      follow-up and a final analysis at 10 years median follow-up will be performed in the main&#xD;
      population (all randomized patients in the AVANT trial including patients lost to follow up&#xD;
      or died).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study.</measure>
    <time_frame>From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) in stage III patients at 8 years median follow-up in the subgroup of alive patients not lost to follow-up after the AVANT trial ending.</measure>
    <time_frame>From randomization until 8 years median follow-up, assessed up to 3 years from the beginning of the S-AVANT study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-Free Survival (DFS) in stage III patients at 8 and 10 years median follow-up.</measure>
    <time_frame>From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse Free Survival (RFS) in patients with stage II and stage III colon cancer.</measure>
    <time_frame>From randomization until first relapse, assessed up to 5 years from the beginning of the S-AVANT study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Specific Survival (CSS) in patients with stage II and stage III colon cancer.</measure>
    <time_frame>From randomization until the date of death related to primary cancer or second primary colon cancer, assessed up to 5 years from the beginning of the S-AVANT study.</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1636</enrollment>
  <condition>Colon Cancer Treated With Bevacizumab After Colon Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with colon cancer included in the AVANT trial and who were randomized between the&#xD;
        three arms of treatment:&#xD;
&#xD;
          -  ARM A: (FOLFOX-4): Oxaliplatin, leucovorin (LV) and 5-fluorouracil (5-FU).&#xD;
&#xD;
          -  ARM B: (FOLFOX-4+bev): Bevacizumab, oxaliplatin, leucovorin (LV) and 5-fluorouracil&#xD;
             (5-FU).&#xD;
&#xD;
          -  ARM C: (XELOX+ bev): Bevacizumab, oxaliplatin in combination with capecitabine.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients randomized in the AVANT trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Written opposition from alive patients&#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>Aimery de Gramont, Pr</last_name>
    <role>Study Director</role>
    <affiliation>GERCOR - Multidisciplinary Oncology Cooperative Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GERCOR</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AVANT</keyword>
  <keyword>GERCOR</keyword>
  <keyword>Follow up</keyword>
  <keyword>Colon cancer</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>Overall survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT02228668
org study id: S-AVANT C13-1
nct id: NCT02228668
lead sponsor: 
collaborator: 
has dmc: No
The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up
      of patients previously included in the AVANT trial from December 2004 to June 2007.

      Clinical data of the AVANT trial will be updated. Neither additional examination nor
      administration of any treatment will be performed on the patients.

      330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium,
      Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece,
      Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway,
      Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden,
      Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).

      The AVANT study aiming at demonstrating superiority of bevacizumab in combination with
      FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when
      adding bevacizumab to chemotherapy in resected stage III colon cancer.

      Adverse events were consistent with the known safety profile of bevacizumab. However, more
      relapses and deaths due to disease progression have been observed in both bevacizumab arms.

      A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term
      results and safety.

      Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected
      at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median
      follow-up (expected to be reached around Q2 2016).

      All analyses will be performed on an exploratory purpose only. An analysis at 8 years median
      follow-up and a final analysis at 10 years median follow-up will be performed in the main
      population (all randomized patients in the AVANT trial including patients lost to follow up
      or died).
observational model: Cohort
time perspective: Other
measure: Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study.
time frame: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.
measure: Overall Survival (OS) in stage III patients at 8 years median follow-up in the subgroup of alive patients not lost to follow-up after the AVANT trial ending.
time frame: From randomization until 8 years median follow-up, assessed up to 3 years from the beginning of the S-AVANT study.
measure: Disease-Free Survival (DFS) in stage III patients at 8 and 10 years median follow-up.
time frame: From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.
measure: Relapse Free Survival (RFS) in patients with stage II and stage III colon cancer.
time frame: From randomization until first relapse, assessed up to 5 years from the beginning of the S-AVANT study.
measure: Cancer Specific Survival (CSS) in patients with stage II and stage III colon cancer.
time frame: From randomization until the date of death related to primary cancer or second primary colon cancer, assessed up to 5 years from the beginning of the S-AVANT study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aimery de Gramont, Pr
role: Study Director
affiliation: GERCOR - Multidisciplinary Oncology Cooperative Group
facility: 
country: France
responsible party type: Sponsor
mesh term: Colonic Neoplasms