<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/NCT02979483</url>
  </required_header>
  <id_info>
    <org_study_id>Urgence Pancreas D16-1</org_study_id>
    <nct_id>NCT02979483</nct_id>
  </id_info>
  <brief_title>Management of Symptomatic Advanced Pancreatic Adenocarcinoma</brief_title>
  <official_title>Management of Symptomatic Advanced Pancreatic Adenocarcinoma: &quot;Urgence Pancreas&quot; - A Prospective A.R.CA.D Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GERCOR - Multidisciplinary Oncology Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GERCOR - Multidisciplinary Oncology Cooperative Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assessed the feasibility and effects of an early integrative supportive care&#xD;
      program in patient with Advanced pancreatic adenocarcinoma (aPDAC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two-step cohort study:&#xD;
&#xD;
      * Step 1 : A 14-day integrative supportive care program initiated as early as the clinical&#xD;
      suspicion of aPDAC.&#xD;
&#xD;
      According to the investigator's assessment of patient needs, this integrative supportive care&#xD;
      program will include:&#xD;
&#xD;
        -  management of pain&#xD;
&#xD;
        -  nutritional support&#xD;
&#xD;
        -  pathologic diagnosis (endoscopy guides or percutaneous biopsies or ascitis cytology)&#xD;
&#xD;
        -  diagnostic computed imaging&#xD;
&#xD;
        -  endoscopic stenting of the bile duct and/or duodenum&#xD;
&#xD;
           * Step 2 : Follow up after the integrative supportive care program. According to their&#xD;
           Eastern Cooperative Oncology Group Performance Status(ECOG PS) and/or chemotherapy&#xD;
&#xD;
        -  Group 1 : Patient becoming eligible for treatment with FOLFIRINOX or nab-paclitaxel +&#xD;
           gemcitabine and / or clinical trial&#xD;
&#xD;
        -  Group 2 :Patient at the end of the 14-day program (Step 1) remaining with either :&#xD;
&#xD;
      a - Persisting ECOG PS ≥ 2&#xD;
&#xD;
      b - Clinico-biological features that make them ineligible to receive the FOLFIRINOX or&#xD;
      nab-paclitaxel + gemcitabine regimens&#xD;
&#xD;
      c - Patient ineligible to other therapeutic clinical trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <phase>N/A</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>STEP 1 : Success rate (feasibility + clinical benefit) of the 14-day integrative supportive care program</measure>
    <time_frame>14 days (+/- 2 days)</time_frame>
    <description>Success of the integrative supportive care program following the first medical appointment in patients who have evocative symptom or pathologically confirmed symptomatic Advanced pancreatic adenocarcinoma (aPDAC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>STEP 2 : 3-month Overall Survival rate</measure>
    <time_frame>Up to 3 months after the beginning of the chemotherapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delay from first symptom of aPDAC to first medical appointment</measure>
    <time_frame>Up to 2-3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay from first medical appointment to beginning of chemotherapy</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients improvement of ECOG PS and clinico-biologic parameters</measure>
    <time_frame>Up to 14-day</time_frame>
    <description>for biologic : livers tests, including bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients receiving chemotherapy</measure>
    <time_frame>At 14 days, at 21 days, Up to death</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of chemotherapy administered</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>type of chemotherapy : FOLFIRINOX, nab-paclitaxel + gemcitabine, gemcitabine alone, FOLFOX7 light or only best supportive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients included in a clinical trial</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison score of Health-related quality of life (HRQoL)</measure>
    <time_frame>Between the score of HRQoL before the program and the score of HRQoL at the end of the 14 days program</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patient included in each group</measure>
    <time_frame>up to two years (after the recruitment of all patients)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival in each group</measure>
    <time_frame>up to two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival in each group</measure>
    <time_frame>up to two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of HRQoL (QLQ-C15 PAL)</measure>
    <time_frame>Month 1 and every two months up to two years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Pancreas</condition>
  <condition>Management Supportive Care Program</condition>
  <arm_group>
    <arm_group_label>Integrative Supportive Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Integrative supportive care</intervention_name>
    <description>At the inclusion, the investigator determine a personalized program of supportive care procedures for each patient (for instance : treatment of pain and nutritional support,stenting of bile duct and/or duodenum, tumor biopsy for pathologic diagnosis ,..)&#xD;
At the end on the integrative supportive care, according to the ECOG-PS of patients , they will be classified into two groups:&#xD;
Group 1 :Good prognosis - ECOG-PS 0-1 and eligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.&#xD;
Patient will be treated by : FOLFIRINOX or gemcitabine-nab-paclitaxel or clinical trial&#xD;
- Group 2 : Poor prognosis - ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.&#xD;
Patients will be treated by: FOLFOX7lightened</description>
    <arm_group_label>Integrative Supportive Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria - STEP 1:&#xD;
&#xD;
          1. Pathologically confirmed or highly suspected aPDAC defined as a pancreatic mass on&#xD;
             imaging, suspected distant metastases, no features suggestive of a neuroendocrine&#xD;
             tumor, and/or clinico-biological abnormalities compatible with the diagnosis of aPDAC,&#xD;
&#xD;
          2. Age ≥ 18 years,&#xD;
&#xD;
          3. Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial&#xD;
             therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine +&#xD;
             nab-paclitaxel,&#xD;
&#xD;
          4. No prior history of cancer, except: in situ breast, cervix cancer, or basal cell&#xD;
             carcinoma and/or complete remission for more than 3 years from another cancer.&#xD;
&#xD;
          5. Registration in France with the French National Health Care System (CMU included)&#xD;
&#xD;
          6. Patient able to comply with study protocol requirements in the view of the&#xD;
             investigator,&#xD;
&#xD;
          7. Before patient registration, written informed consent must be obtained according to&#xD;
             ICH/GCP and national/local regulations,&#xD;
&#xD;
          8. Patients requiring at least two components of the integrative care program (pain&#xD;
             management, nutritional management, pathological assessment or imaging, and&#xD;
             endoscopy/stent).&#xD;
&#xD;
        Exclusion Criteria - STEP 1 :&#xD;
&#xD;
          1. Any medical, psychological, familial, sociological, or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule; those&#xD;
             conditions should be discussed with the patient before registration in the trial,&#xD;
&#xD;
          2. Patient protected by law,&#xD;
&#xD;
          3. Pregnant or breast feeding women&#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>Benoît ROUSSEAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Henri Mondor Créteil</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benoît ROUSSEAU, MD</last_name>
    <email>benoit.rousseau@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Sainte Catherine</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe DEBOURDEAU, MD</last_name>
    </contact>
    <investigator>
      <last_name>Philippe DEBOURDEAU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pascal HAMMEL, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pascal HAMMEL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benoît ROUSSEAU, MD</last_name>
    </contact>
    <investigator>
      <last_name>Benoît ROUSSEAU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois Perret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aimery DE GRAMONT, MD</last_name>
    </contact>
    <investigator>
      <last_name>Aimery DE GRAMONT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christelle De la FOUCHARDIERE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Christelle de la FOUCHARDIERE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Layne</name>
      <address>
        <city>Mont de Marsan</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jérôme DAUBA, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jérôme DAUBA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Grope Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric RAYMOND, MD</last_name>
    </contact>
    <investigator>
      <last_name>Eric RAYMOND, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Romain CORIAT, MD</last_name>
    </contact>
    <investigator>
      <last_name>Romain CORIAT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Baptiste BACHET, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jean Baptiste BACHET, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe LOUVET, MD</last_name>
    </contact>
    <investigator>
      <last_name>Christophe LOUVET, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopitaux du Léman</name>
      <address>
        <city>Thonon les Bains</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed BEDJAOUI, MD</last_name>
    </contact>
    <investigator>
      <last_name>Ahmed BEDJAOUI, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Tours - Hôpital Trousseau</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry LECOMTE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Thierry LECOMTE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</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/NCT02979483
org study id: Urgence Pancreas D16-1
nct id: NCT02979483
lead sponsor: 
has dmc: No
This study assessed the feasibility and effects of an early integrative supportive care
      program in patient with Advanced pancreatic adenocarcinoma (aPDAC).
Two-step cohort study:

      * Step 1 : A 14-day integrative supportive care program initiated as early as the clinical
      suspicion of aPDAC.

      According to the investigator's assessment of patient needs, this integrative supportive care
      program will include:

        -  management of pain

        -  nutritional support

        -  pathologic diagnosis (endoscopy guides or percutaneous biopsies or ascitis cytology)

        -  diagnostic computed imaging

        -  endoscopic stenting of the bile duct and/or duodenum

           * Step 2 : Follow up after the integrative supportive care program. According to their
           Eastern Cooperative Oncology Group Performance Status(ECOG PS) and/or chemotherapy

        -  Group 1 : Patient becoming eligible for treatment with FOLFIRINOX or nab-paclitaxel +
           gemcitabine and / or clinical trial

        -  Group 2 :Patient at the end of the 14-day program (Step 1) remaining with either :

      a - Persisting ECOG PS ≥ 2

      b - Clinico-biological features that make them ineligible to receive the FOLFIRINOX or
      nab-paclitaxel + gemcitabine regimens

      c - Patient ineligible to other therapeutic clinical trial
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: STEP 1 : Success rate (feasibility + clinical benefit) of the 14-day integrative supportive care program
time frame: 14 days (+/- 2 days)
description: Success of the integrative supportive care program following the first medical appointment in patients who have evocative symptom or pathologically confirmed symptomatic Advanced pancreatic adenocarcinoma (aPDAC)
measure: STEP 2 : 3-month Overall Survival rate
time frame: Up to 3 months after the beginning of the chemotherapy
measure: Delay from first symptom of aPDAC to first medical appointment
time frame: Up to 2-3 months
measure: Delay from first medical appointment to beginning of chemotherapy
time frame: Up to 1 month
measure: Rate of patients improvement of ECOG PS and clinico-biologic parameters
time frame: Up to 14-day
description: for biologic : livers tests, including bilirubin
measure: Rate of patients receiving chemotherapy
time frame: At 14 days, at 21 days, Up to death
measure: Type of chemotherapy administered
time frame: Up to 14 days
description: type of chemotherapy : FOLFIRINOX, nab-paclitaxel + gemcitabine, gemcitabine alone, FOLFOX7 light or only best supportive care
measure: Rate of patients included in a clinical trial
time frame: Up to 14 days
measure: Comparison score of Health-related quality of life (HRQoL)
time frame: Between the score of HRQoL before the program and the score of HRQoL at the end of the 14 days program
measure: Rate of patient included in each group
time frame: up to two years (after the recruitment of all patients)
measure: Progression free survival in each group
time frame: up to two years
measure: Overall survival in each group
time frame: up to two years
measure: Score of HRQoL (QLQ-C15 PAL)
time frame: Month 1 and every two months up to two years
arm group label: Integrative Supportive Care
arm group type: Other
description: All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days)
intervention type: Procedure
intervention name: Integrative supportive care
description: At the inclusion, the investigator determine a personalized program of supportive care procedures for each patient (for instance : treatment of pain and nutritional support,stenting of bile duct and/or duodenum, tumor biopsy for pathologic diagnosis ,..)
At the end on the integrative supportive care, according to the ECOG-PS of patients , they will be classified into two groups:
Group 1 :Good prognosis - ECOG-PS 0-1 and eligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.
Patient will be treated by : FOLFIRINOX or gemcitabine-nab-paclitaxel or clinical trial
- Group 2 : Poor prognosis - ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.
Patients will be treated by: FOLFOX7lightened
arm group label: Integrative Supportive Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benoît ROUSSEAU, MD
role: Principal Investigator
affiliation: CHU Henri Mondor Créteil
last name: Benoît ROUSSEAU, MD
email: benoit.rousseau@aphp.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma