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/NCT05988814</url>
    </required_header>
    <id_info>
      <org_study_id>2023-505889-29-00</org_study_id>
      <nct_id>NCT05988814</nct_id>
    </id_info>
    <brief_title>Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy</brief_title>
    <acronym>FOLFIRINOX3 P</acronym>
    <official_title>Phase II Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy (FOLFIRINOX3 Pancréas)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Georges Francois Leclerc</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Georges Francois Leclerc</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>
        Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with&#xD;
        locally advanced unresectable or metastatic pancreatic cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with&#xD;
        locally advanced unresectable or metastatic pancreatic cancer.&#xD;
  &#xD;
        Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two&#xD;
        8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be&#xD;
        administered until progression.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2028</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>6 months</time_frame>
      <description>Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>24 months</time_frame>
      <description>Overall survival (OS) is defined as the time interval between the date of inclusion and the date of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute and late toxicities (adverses events)</measure>
      <time_frame>Until 30 days after the end of treatment</time_frame>
      <description>Acute toxicity is defined as toxicity occurring within 6 months of the start of chemotherapy.&#xD;
  A toxicity is late if it occurs more than 6 months after the start of chemotherapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QoL)</measure>
      <time_frame>Until the end of treatment an average of 14 months</time_frame>
      <description>Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the cancer-specific QLQ-C30</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QoL)</measure>
      <time_frame>Until the end of treatment an average of 14 months</time_frame>
      <description>Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the QLQPAN26,a module specific to pancreatic cancer.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Metastatic Pancreatic Cancer</condition>
    <arm_group>
      <arm_group_label>FOLFIRINOX treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.&#xD;
  Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>FOLFIRINOX treatment</intervention_name>
      <description>Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.&#xD;
  Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression</description>
      <arm_group_label>FOLFIRINOX treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female age &gt; 18 years at time of study entry&#xD;
  &#xD;
            -  Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group&#xD;
               (ECOG)&#xD;
  &#xD;
            -  Patients with pancreatic adenocarcinoma&#xD;
  &#xD;
            -  Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic&#xD;
               cancer&#xD;
  &#xD;
            -  Patients with no history of chemotherapy (prior adjuvant or neoadjuvant chemotherapy&#xD;
               accepted if the time between the end of chemotherapy and recurrence is greater than 12&#xD;
               months) and no history of curative radiotherapy for metastatic or locally advanced&#xD;
               disease. Palliative radiotherapy is accepted.&#xD;
  &#xD;
            -  Patient eligible for treatment with FOLFIRINOX (5-FU, Irinotecan, Oxaliplatin and&#xD;
               folinic acid) including but not limited to: No active heart disease An ECG with a&#xD;
               QT/QTc interval ˂ to 450 ms for men and ˂ to 470 ms for women. No uncontrolled&#xD;
               hypertension defined by systolic pressure &gt; 140 mmHg or diastolic pressure &gt; 90 mmHg&#xD;
               despite optimal medical management. A negative pregnancy test if applicable&#xD;
  &#xD;
            -  Tumor evaluation (CT scan) performed within 4 weeks (28 days) prior to inclusion with&#xD;
               at least one measurable lesion according to RECIST 1.1 criteria&#xD;
  &#xD;
            -  Patient fit and able to comply with the protocol for the duration of the study,&#xD;
               including treatment, visits, scheduled examinations and follow-up.&#xD;
  &#xD;
            -  Biological, hepatic, renal and serological data within the following limits (tests&#xD;
               performed within 7 days of inclusion except for serologies performed within 28 days)&#xD;
  &#xD;
            -  Information given and informed consent signed&#xD;
  &#xD;
            -  Patient affiliated to a social security scheme&#xD;
  &#xD;
            -  Men and women must have an effective contraceptive method.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with neuroendocrine carcinoma or acinar cell carcinoma&#xD;
  &#xD;
            -  Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ&#xD;
               of the uterine cervix or cutaneous basal cell carcinoma).&#xD;
  &#xD;
            -  Presence of brain metastasis(es)&#xD;
  &#xD;
            -  Estimated prognosis &lt; 3 months&#xD;
  &#xD;
            -  History of grade 4 toxicity to oxaliplatin, irinotecan or 5FU if history of&#xD;
               adjuvant/neoadjuvant chemotherapy&#xD;
  &#xD;
            -  Sequellar toxicity &gt; grade 1 if previous adjuvant/neoadjuvant chemotherapy&#xD;
  &#xD;
            -  Hypersensitivity to any component of FOLFIRINOX® treatment.&#xD;
  &#xD;
            -  Current participation or participation within 30 days prior to inclusion in another&#xD;
               therapeutic trial with an investigational compound and/or completion of radiotherapy&#xD;
               within 10 days prior to the start of treatment&#xD;
  &#xD;
            -  Evidence of a homozygous or heterozygous DPYD mutation and/or uracilemia &gt;16ng/mL&#xD;
               and/or homozygous UGT1A1 genotype.&#xD;
  &#xD;
            -  Pregnancy, breastfeeding&#xD;
  &#xD;
            -  Inability to sign informed consent or to undergo medical monitoring of the trial for&#xD;
               geographical, social or psychological reasons including, but not limited to,&#xD;
               psychiatric illness compromising comprehension of information or conduct of the study.&#xD;
  &#xD;
            -  Patient under guardianship, curatorship or safeguard of justice.&#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>Jean-David FUMET, Dr</last_name>
      <phone>380737538</phone>
      <phone_ext>+33</phone_ext>
      <email>jdfumet@cgfl.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sophie PARNALLAND, Project manager</last_name>
      <phone>345348077</phone>
      <phone_ext>+33</phone_ext>
      <email>sparnalland@cgfl.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>FOLFIRINOX treatment</keyword>
    <keyword>pancreatic cancer</keyword>
    <keyword>first line chemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Folfirinox</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05988814
  org study id: 2023-505889-29-00
  nct id: NCT05988814
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with
        locally advanced unresectable or metastatic pancreatic cancer.
  Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with
        locally advanced unresectable or metastatic pancreatic cancer.
  
        Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two
        8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be
        administered until progression.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-free survival (PFS)
  time frame: 6 months
  description: Progression-free survival (PFS) on FOLFIRINOX3 at 6 months.
  measure: Overall survival (OS)
  time frame: 24 months
  description: Overall survival (OS) is defined as the time interval between the date of inclusion and the date of death from any cause.
  measure: Acute and late toxicities (adverses events)
  time frame: Until 30 days after the end of treatment
  description: Acute toxicity is defined as toxicity occurring within 6 months of the start of chemotherapy.
  A toxicity is late if it occurs more than 6 months after the start of chemotherapy.
  measure: Quality of life (QoL)
  time frame: Until the end of treatment an average of 14 months
  description: Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the cancer-specific QLQ-C30
  measure: Quality of life (QoL)
  time frame: Until the end of treatment an average of 14 months
  description: Quality of life (QoL) will be assessed at inclusion, every 4 courses up to 6 months, then every 8 courses using questionnaires validated by the EORTC (European Organisation for Research and Treatment of Cancer): the QLQPAN26,a module specific to pancreatic cancer.
  arm group label: FOLFIRINOX treatment
  arm group type: Experimental
  description: Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.
  Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.
  intervention type: Drug
  intervention name: FOLFIRINOX treatment
  description: Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.
  Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression
  arm group label: FOLFIRINOX treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jean-David FUMET, Dr
  phone: 380737538
  phone ext: +33
  email: jdfumet@cgfl.fr
  last name: Sophie PARNALLAND, Project manager
  phone: 345348077
  phone ext: +33
  email: sparnalland@cgfl.fr
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms
  mesh term: Folfirinox