<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/NCT03301454</url>
  </required_header>
  <id_info>
    <org_study_id>E-DIS2-1705</org_study_id>
    <secondary_id>2017-003660-13</secondary_id>
    <secondary_id>170757A-12</secondary_id>
    <nct_id>NCT03301454</nct_id>
  </id_info>
  <brief_title>Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer</brief_title>
  <acronym>E-DIS2</acronym>
  <official_title>Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Oscar Lambret</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Oscar Lambret</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase II study, randomized, open-label, multicentric, willing to establish the benefit of&#xD;
      pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in&#xD;
      two successive phases :&#xD;
&#xD;
        -  non randomized phase in which all patients will undergo chemotherapy&#xD;
&#xD;
        -  second phase in which only non progressive patients are going to be randomized&#xD;
           (&quot;discontinuation design&quot;). Patients that will show progression in their disease during&#xD;
           the first 6 weeks will be released of the study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² -&#xD;
      5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100&#xD;
      mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical&#xD;
      exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the&#xD;
      patient will proceed to the randomized phase.&#xD;
&#xD;
      Randomized phase:&#xD;
&#xD;
        -  Arm A : pursuit of chemotherapy and best supportive care&#xD;
&#xD;
        -  Arm B : interruption of chemotherapy and best supportive care&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the overall survival for patients suffering from Esophageal cancer</measure>
    <time_frame>From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment</time_frame>
    <description>Non-progressive disease at and after 6 weeks of treatment until progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate efficiency in term of overall survival, of pursuing chemotherapy</measure>
    <time_frame>From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment</time_frame>
    <description>beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the efficiency in term of progression-free of pursuing chemotherapy</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment</time_frame>
    <description>beyond 6 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the rate of non progressive patients</measure>
    <time_frame>From date of inclusion until the date of the end the 6 firsts weeks of treatment</time_frame>
    <description>after the 6 firsts weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the overall survival of the whole study population</measure>
    <time_frame>From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment</time_frame>
    <description>beyond the inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the toxicity of chemotherapy</measure>
    <time_frame>from baseline up to 12 months</time_frame>
    <description>during the initial treatment phase compared to the 2 treatment arms after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the consequences of pursuing chemotherapy</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment</time_frame>
    <description>beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Esophageal Cancer, Squamous Cell</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pursuit of chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Interruption of chemotherapy, best supportive care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pursuit of chemotherapy</intervention_name>
    <description>Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>LV5FU2-paclitaxel CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from squamous-cell type esophageal cancer histologically proved&#xD;
&#xD;
          -  Metastatic disease measurable according to RECIST criteria. Patients with metachronous&#xD;
             metastasis and who have been treated with surgery (+/- radio chemotherapy concurrent&#xD;
             or adjuvant chemotherapy) or exclusive radio chemotherapy, are eligible&#xD;
&#xD;
          -  Patients who show progress under chemotherapy that associates a fluoropyrimidine with&#xD;
             a platinum salt&#xD;
&#xD;
          -  Man or woman over 18 years old&#xD;
&#xD;
          -  ECOG performance status ≤ 2&#xD;
&#xD;
          -  Adequate haematological, renal and hepatic functions : PNN ≥ 1500/ mm3; platelets ≥&#xD;
             100 000/ mm3; Haemoglobin ≥ 9.0 g/dL; ALT and AST ≤ 2.5 ULN (≤ 5.0 in case of liver&#xD;
             metastases); Total bilirubin ≤ 1.5 X ULN; Serum creatinine ≤ 1.5 ULN&#xD;
&#xD;
          -  Efficient contraceptive method for both gender (if applicable), during the whole&#xD;
             treatment period and the 6 months following the last treatment administration&#xD;
&#xD;
          -  Affiliation to the National Social Security System&#xD;
&#xD;
          -  With informed and signed consent&#xD;
&#xD;
        Inclusion Criteria for randomization:&#xD;
&#xD;
          -  ECOG performance status ≤ 2&#xD;
&#xD;
          -  Able to pursuit the LV5FU2-paclitaxel chemotherapy&#xD;
&#xD;
          -  Non-progressive disease after the initial phase (first tumor exam at week 6)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received more than one line of chemotherapy for a metastatic disease&#xD;
&#xD;
          -  Presence of other evolutive tumors&#xD;
&#xD;
          -  Cerebral metastasis or other known brain tumors&#xD;
&#xD;
          -  Severe liver failure&#xD;
&#xD;
          -  Pernicious anemia or other anemia due to vitamin B12 defficiency&#xD;
&#xD;
          -  Hypersensibility to an active substance or any other excipients of experimental drugs&#xD;
&#xD;
          -  Every unstable chronicle diseases that can affect patient confidence or security&#xD;
&#xD;
          -  Clinically significant active cardiac disease or myocardial infarction in the 6&#xD;
             previous months&#xD;
&#xD;
          -  Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency&#xD;
&#xD;
          -  Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin&#xD;
&#xD;
          -  Live attenuated vaccine within the 3 previous months&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Unable to comply with the medical monitoring for geographic, social or mental issues&#xD;
&#xD;
          -  Patient Under guardianship or tutorship&#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>Farid EL HAJBI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Oscar Lambret</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie VANSEYMORTIER</last_name>
    <phone>33320295918</phone>
    <email>promotion@o-lambret.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Amiens</city>
        <zip>80080</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Vincent HAUTEFEUILLE, MD</last_name>
      <phone>+33322088849</phone>
      <email>heutefeuille.vincent@chu-amiens.fr</email>
    </contact>
    <investigator>
      <last_name>Vincent HAUTEFEUILLE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Paul Papin</name>
      <address>
        <city>Angers</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier CAPITAIN, MD</last_name>
      <phone>+33240679900</phone>
      <email>olivier.capitain@ico.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Olivier CAPITAIN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Véronique GUERIN-MEYER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julie VANBOCKSTAEL, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marie-Pierre GALAIS, MD</last_name>
      <phone>+33231455016</phone>
      <email>mp.galais@baclesse.fr</email>
    </contact>
    <investigator>
      <last_name>Marie-Pierre GALAIS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Françoise POLYCARPE-OSAER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aurélie PARZY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphane CORBINAIS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Farid EL HAJBI, MD</last_name>
      <phone>+33320295266</phone>
      <email>f-elhajbi@o-lambret.fr</email>
    </contact>
    <investigator>
      <last_name>Frederik LAESTADIUS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diane PANNIER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Natacha STERN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas PENEL, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas RYCKEWAERT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre René Gauducheau</name>
      <address>
        <city>Nantes</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier CAPITAIN, MD</last_name>
      <phone>+33240679900</phone>
      <email>olivier.capitain@ico.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Hélène SENELLART, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandrine HIRET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olivier CAPITAIN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Judith RAIMBOURG, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie</name>
      <address>
        <city>Plérin</city>
        <zip>22190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierre-Luc ETIENNE, MD</last_name>
      <phone>+33296752216</phone>
      <email>pl.etienne@cario-sante.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre-Luc ETIENNE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jérôme MARTIN-BABAU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dominique BESSON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne-Claire HARDY-BESSARD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julien EDELINE, Pr</last_name>
      <phone>+33299253000</phone>
      <email>j.edeline@rennes.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Samuel LE SOURD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anais BODERE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien EDELINE, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claire LARIBLE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fanny LE DU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Astrid LIEVRE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc PRACHT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</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>Esophageal Neoplasms</mesh_term>
    <mesh_term>Neoplasms, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03301454
org study id: E-DIS2-1705
secondary id: 2017-003660-13
secondary id: 170757A-12
nct id: NCT03301454
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Phase II study, randomized, open-label, multicentric, willing to establish the benefit of
      pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in
      two successive phases :

        -  non randomized phase in which all patients will undergo chemotherapy

        -  second phase in which only non progressive patients are going to be randomized
           ("discontinuation design"). Patients that will show progression in their disease during
           the first 6 weeks will be released of the study
Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² -
      5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100
      mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical
      exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the
      patient will proceed to the randomized phase.

      Randomized phase:

        -  Arm A : pursuit of chemotherapy and best supportive care

        -  Arm B : interruption of chemotherapy and best supportive care
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Estimate the overall survival for patients suffering from Esophageal cancer
time frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
description: Non-progressive disease at and after 6 weeks of treatment until progression
measure: Estimate efficiency in term of overall survival, of pursuing chemotherapy
time frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
description: beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks
measure: Estimate the efficiency in term of progression-free of pursuing chemotherapy
time frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
description: beyond 6 weeks of treatment
measure: Estimate the rate of non progressive patients
time frame: From date of inclusion until the date of the end the 6 firsts weeks of treatment
description: after the 6 firsts weeks of treatment
measure: Estimate the overall survival of the whole study population
time frame: From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
description: beyond the inclusion
measure: Measure the toxicity of chemotherapy
time frame: from baseline up to 12 months
description: during the initial treatment phase compared to the 2 treatment arms after randomization
measure: Estimate the consequences of pursuing chemotherapy
time frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
description: beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits
arm group label: Arm A
arm group type: Experimental
description: Pursuit of chemotherapy.
arm group label: Arm B
arm group type: No Intervention
description: Interruption of chemotherapy, best supportive care
intervention type: Drug
intervention name: pursuit of chemotherapy
description: Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment
arm group label: Arm A
other name: LV5FU2-paclitaxel CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farid EL HAJBI, MD
role: Principal Investigator
affiliation: Centre Oscar Lambret
last name: Marie VANSEYMORTIER
phone: 33320295918
email: promotion@o-lambret.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
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investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
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investigator: 
country: France
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Neoplasms, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Paclitaxel
sharing ipd: No