xml: <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/NCT06006728</url>
    </required_header>
    <id_info>
      <org_study_id>CHUBX 2023/14</org_study_id>
      <nct_id>NCT06006728</nct_id>
    </id_info>
    <brief_title>Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy</brief_title>
    <acronym>NALIRI-PANC</acronym>
    <official_title>Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Bordeaux</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Servier</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Bordeaux</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objectives of the study are to evaluate the efficacy (primary endpoint: overall&#xD;
        survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of&#xD;
        nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be&#xD;
        effective after gemcitabine-based treatment in patients with metastatic pancreatic&#xD;
        adenocarcinoma in the phase III NAPOLI-1 randomized trial.&#xD;
  &#xD;
        Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and&#xD;
        leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR =&#xD;
        0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.&#xD;
  &#xD;
        However, patients included in clinical trials regularly differ from patients in routine&#xD;
        practice, and a real-life study is fundamental in this poor prognosis situation where quality&#xD;
        of life preservation is paramount&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Response rate to treatment</measure>
      <time_frame>Every 3 months up to 3 years</time_frame>
      <description>Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI).&#xD;
  Duration of treatment is calculated from the day of nal-IRI initiation to the day of disease progression, switch to other treatment regimens or when the patient is lost to follow-up.&#xD;
  Tumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>Every 3 months up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost evaluation</measure>
      <time_frame>Every 3 months up to 3 years</time_frame>
      <description>number of vials per patient</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Pancreatic Adenocarcinoma Metastatic</condition>
    <arm_group>
      <arm_group_label>naliri</arm_group_label>
      <description>Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for&#xD;
          metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  histological or cytological confirmation of pancreatic ductal adenocarcinoma&#xD;
  &#xD;
            -  measurable lesion(s)&#xD;
  &#xD;
            -  progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant&#xD;
               protocol (only if remote metastases developed within 6 months of the end of adjuvant&#xD;
               treatment), locally advanced, or metastatic phase. They may have already received&#xD;
               irinotecan and/or fluorouracil.&#xD;
  &#xD;
            -  Performance Status (PS) 0 or 1&#xD;
  &#xD;
            -  Oral consent&#xD;
  &#xD;
            -  Health insurance&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)&#xD;
  &#xD;
            -  thromboembolic events within six months of inclusion;&#xD;
  &#xD;
            -  Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled&#xD;
               hypertension.&#xD;
  &#xD;
            -  Patient under legal protection&#xD;
  &#xD;
            -  Hypersensitivity to irinotecan&#xD;
  &#xD;
            -  Breast feeding&#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_contact>
      <last_name>Marie DECRAECKER, MD</last_name>
      <phone>+335.57.65.64.38</phone>
      <email>marie.decraecker@chu-bordeaux.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Bordeaux</name>
        <address>
          <city>Pessac</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marie Decraecker, MD</last_name>
        <phone>+335.57.65.64.38</phone>
        <email>marie.decraecker@chu-bordeaux.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pancreatic adenocarcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006728
  org study id: CHUBX 2023/14
  nct id: NCT06006728
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objectives of the study are to evaluate the efficacy (primary endpoint: overall
        survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of
        nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice
  Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be
        effective after gemcitabine-based treatment in patients with metastatic pancreatic
        adenocarcinoma in the phase III NAPOLI-1 randomized trial.
  
        Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and
        leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR =
        0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.
  
        However, patients included in clinical trials regularly differ from patients in routine
        practice, and a real-life study is fundamental in this poor prognosis situation where quality
        of life preservation is paramount
  observational model: Case-Only
  time perspective: Retrospective
  measure: Overall survival
  time frame: Up to 3 years
  measure: Response rate to treatment
  time frame: Every 3 months up to 3 years
  description: Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI).
  Duration of treatment is calculated from the day of nal-IRI initiation to the day of disease progression, switch to other treatment regimens or when the patient is lost to follow-up.
  Tumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9.
  measure: Progression-free survival
  time frame: Every 3 months up to 3 years
  measure: Cost evaluation
  time frame: Every 3 months up to 3 years
  description: number of vials per patient
  arm group label: naliri
  description: Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marie DECRAECKER, MD
  phone: +335.57.65.64.38
  email: marie.decraecker@chu-bordeaux.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  sharing ipd: No