<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/NCT01697488</url>
  </required_header>
  <id_info>
    <org_study_id>ML27765</org_study_id>
    <nct_id>NCT01697488</nct_id>
  </id_info>
  <brief_title>An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)</brief_title>
  <official_title>Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal 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 safety, efficacy, quality of life and&#xD;
      predictive/selection factors for Avastin (bevacizumab) in combination with&#xD;
      carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian&#xD;
      tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be&#xD;
      collected during up to 15 months of treatment and 12 months of follow-up. A second&#xD;
      recruitment phase has been opened to focus on patients &gt;/= 70 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2012</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">September 27, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Progression-free survival</measure>
    <time_frame>up to approximately 27 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires</measure>
    <time_frame>up to approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics</measure>
    <time_frame>approximately 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment discontinuations/modifications</measure>
    <time_frame>approximately 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment duration</measure>
    <time_frame>approximately 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1090</enrollment>
  <condition>Peritoneal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Overall sample</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subgroup</arm_group_label>
    <description>Patients aged &gt;/= 70 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary&#xD;
        peritoneal cancer with indication for first-line carboplatin/paclitaxel chemotherapy in&#xD;
        combination with Avastin. In the second study phase recruitment focusses on patients &gt;/= 70&#xD;
        years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study phase 1: Patients aged &gt;/= 18 years&#xD;
&#xD;
          -  Study phase 2: Patients aged &gt;/= 70 years&#xD;
&#xD;
          -  Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or&#xD;
             primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel&#xD;
             chemotherapy in combination with Avastin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to Avastin according to Summary of Product Characteristics&#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>
      <name>Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie</name>
      <address>
        <city>Offenburg</city>
        <zip>77652</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2019</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>Peritoneal 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/NCT01697488
org study id: ML27765
nct id: NCT01697488
lead sponsor: 
This observational study will evaluate the safety, efficacy, quality of life and
      predictive/selection factors for Avastin (bevacizumab) in combination with
      carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian
      tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be
      collected during up to 15 months of treatment and 12 months of follow-up. A second
      recruitment phase has been opened to focus on patients >/= 70 years.
observational model: Cohort
time perspective: Prospective
measure: Efficacy: Progression-free survival
time frame: up to approximately 27 months
measure: Safety: Incidence of adverse events
time frame: approximately 5 years
measure: Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires
time frame: up to approximately 27 months
measure: Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics
time frame: approximately 5 years
measure: Treatment discontinuations/modifications
time frame: approximately 5 years
measure: Treatment duration
time frame: approximately 5 years
arm group label: Cohort
description: Overall sample
arm group label: Subgroup
description: Patients aged >/= 70 years
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: Germany
responsible party type: Sponsor
mesh term: Peritoneal Neoplasms