<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/NCT02264665</url>
  </required_header>
  <id_info>
    <org_study_id>A6181214</org_study_id>
    <secondary_id>OPALINE</secondary_id>
    <nct_id>NCT02264665</nct_id>
  </id_info>
  <brief_title>OPALINE : A Study Of Morbidity And Mortality At 2 Years</brief_title>
  <acronym>OPALINE</acronym>
  <official_title>AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keyrus Biopharma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A descriptive, prospective (partly retrospective), multisite, observational study conducted&#xD;
      in France in adult patients treated for a well differentiated, unresectable or metastatic,&#xD;
      pancreatic neuroendocrine tumor with disease progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      prospective and retrospective Analyses will be performed using SAS® software&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2015</start_date>
  <completion_date type="Actual">November 18, 2019</completion_date>
  <primary_completion_date type="Actual">November 18, 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>progression-free survival</measure>
    <time_frame>at baseline, each 3 to 4 months up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>at baseline, each 3 to 4 months up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>at baseline, each 3 to 4 months up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient demographic characteristics</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of subjects using targeted therapy at baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in treatment therapy received</measure>
    <time_frame>approximately every 3 months up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of subjects using therapy other than targeted at baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">147</enrollment>
  <condition>Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive</condition>
  <arm_group>
    <arm_group_label>Sunitinib</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Afinitor</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>other treatment (chémotherapy, SSA..)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sunitinib</intervention_name>
    <description>sunitinib 37.5mg/d orally</description>
    <arm_group_label>Sunitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>everolimus</intervention_name>
    <description>everolimus 10mg/d orally</description>
    <arm_group_label>Afinitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapies recommended in france</intervention_name>
    <description>depends on the chemotherapy prescribed (IV)</description>
    <arm_group_label>other treatment (chémotherapy, SSA..)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with progressive, metastatic or unresectable, and well differentiated pancreatic&#xD;
        neuroendocrine tumors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age;&#xD;
&#xD;
          -  Patients treated with a targeted therapy (sunitinib, everolimus) or with other&#xD;
             treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin&#xD;
             analog)* for:&#xD;
&#xD;
             *Patients whose treatment line (targeted therapy or other treatment) is initiated as a&#xD;
             1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or&#xD;
             patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment&#xD;
             was initiated in the site in which the patient is enrolled in the study (prevalent&#xD;
             patients); a change of line is defined as a change in molecule or combination.&#xD;
&#xD;
          -  A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor;&#xD;
&#xD;
          -  Well-differentiated;&#xD;
&#xD;
          -  Progressive prior to initiation of treatment in the investigator's judgment (clinical&#xD;
             or radiological progression);&#xD;
&#xD;
          -  Patients who have been informed of the conditions of the study and who have signed the&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of poorly differentiated neuroendocrine carcinoma or an&#xD;
             adenoneuroendocrine carcinoma.&#xD;
&#xD;
          -  Patients receiving targeted therapy (everolimus or sunitinib) already received in a&#xD;
             previous line of treatment (rechallenged patient).&#xD;
&#xD;
          -  Patients refusing to give consent.&#xD;
&#xD;
          -  Patients receiving a fifth line or subsequent line of systemic treatment.&#xD;
&#xD;
          -  Patients participating in a clinical trial in a treatment arm not validated by the MA&#xD;
             and the TNCD according to the version dated December 2013.&#xD;
&#xD;
          -  Patients randomized to the placebo arm of a placebo-controlled trial or to a&#xD;
             double-blind trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU d'Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint-Andre</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Medical</name>
      <address>
        <city>Challes Les Eaux</city>
        <zip>73190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Tours - Hôpital TROUSSEAU</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital d'Estaing</name>
      <address>
        <city>Clermont Ferrand Cedex</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital du Bocage</name>
      <address>
        <city>Dijon Cedex</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unite d'Oncologie Digestive, Departement d'HGE</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Dupuytren Service Oncologie</name>
      <address>
        <city>Limoges</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Bretagne Sud</name>
      <address>
        <city>Lorient</city>
        <zip>56100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H</name>
      <address>
        <city>Lyon Cedex 3</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Edouard Herriot, Pavillion O, Oncologie Medicale</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital La Timone Service de Gastroenterologie et Oncologie Digestive</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'Annecy</name>
      <address>
        <city>Metz Tessy</city>
        <zip>74370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Val D'Aurelle-Paul Lamarque</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRLC Val d'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de LA Source, Centre Hospitalier Regional</name>
      <address>
        <city>Orleans CEDEX 2</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Cochin</name>
      <address>
        <city>Paris Cedex</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Jean</name>
      <address>
        <city>Perpignan Cedex</city>
        <zip>66046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut Lévèque</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Cornouaille</name>
      <address>
        <city>Quimper Cedex</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.U. de Reims - Hôpital Robert Debré</name>
      <address>
        <city>Reims cedex</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Robert Debre, Service D'Hepato-gastro-enterolo</name>
      <address>
        <city>Reims CEDEX</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Armoricaine</name>
      <address>
        <city>Saint Brieuc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste de l'estuaire</name>
      <address>
        <city>Saint-Nazaire Cedex</city>
        <zip>44606</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pôle Hospitalier Mutualiste</name>
      <address>
        <city>Saint-Nazaire</city>
        <zip>44600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition</name>
      <address>
        <city>Strasbourg Cedex</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch, Onco Hermatologie</name>
      <address>
        <city>Suresnes cedex</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Medical</name>
      <address>
        <city>Vannes</city>
        <zip>56000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181214&amp;StudyName=Observational%20Study%20In%20Real%20Life%20Settings%20Of%20The%20Systemic%20Treatment%20Of%20Well%20Differentiated%2C%20Unresectable%20Or%20Metastatic%2C%20Progressive%20Panc</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>December 30, 2019</last_update_submitted>
  <last_update_submitted_qc>December 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</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>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Adenoma, Islet Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Sunitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>December 14, 2022</submitted>
  </pending_results>
  <!-- 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/NCT02264665
org study id: A6181214
secondary id: OPALINE
nct id: NCT02264665
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A descriptive, prospective (partly retrospective), multisite, observational study conducted
      in France in adult patients treated for a well differentiated, unresectable or metastatic,
      pancreatic neuroendocrine tumor with disease progression.
prospective and retrospective Analyses will be performed using SAS® software
observational model: Cohort
time perspective: Other
measure: progression-free survival
time frame: at baseline, each 3 to 4 months up to 2 years
measure: Overall survival
time frame: at baseline, each 3 to 4 months up to 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: at baseline, each 3 to 4 months up to 2 years
measure: Patient demographic characteristics
time frame: baseline
measure: number of subjects using targeted therapy at baseline
time frame: Baseline
measure: Change from baseline in treatment therapy received
time frame: approximately every 3 months up to 2 years
measure: number of subjects using therapy other than targeted at baseline
time frame: Baseline
arm group label: Sunitinib
arm group label: Afinitor
arm group label: other treatment (chémotherapy, SSA..)
intervention type: Drug
intervention name: sunitinib
description: sunitinib 37.5mg/d orally
arm group label: Sunitinib
intervention type: Drug
intervention name: everolimus
description: everolimus 10mg/d orally
arm group label: Afinitor
intervention type: Drug
intervention name: chemotherapies recommended in france
description: depends on the chemotherapy prescribed (IV)
arm group label: other treatment (chémotherapy, SSA..)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: France
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181214&StudyName=Observational%20Study%20In%20Real%20Life%20Settings%20Of%20The%20Systemic%20Treatment%20Of%20Well%20Differentiated%2C%20Unresectable%20Or%20Metastatic%2C%20Progressive%20Panc
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
mesh term: Adenoma, Islet Cell
mesh term: Everolimus
mesh term: Sunitinib
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
submitted: December 14, 2022