<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/NCT01717924</url>
  </required_header>
  <id_info>
    <org_study_id>2011_25</org_study_id>
    <secondary_id>2012-000998-24</secondary_id>
    <nct_id>NCT01717924</nct_id>
  </id_info>
  <brief_title>Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma</brief_title>
  <acronym>ADCI002</acronym>
  <official_title>Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federation Francophone de Cancerologie Digestive</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federation of Research in Surgery (FRENCH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled&#xD;
      trial comparing primary surgery versus primary chemotherapy followed by surgery in patients&#xD;
      with a resectable signet ring cell gastric adenocarcinoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Anticipated">November 2027</completion_date>
  <primary_completion_date type="Anticipated">November 2027</primary_completion_date>
  <phase>N/A</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>Percentage of patients dead in the 2-years</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival at 2 years</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival at 3 years</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival at 3 years</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>within 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>grade III/IV toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>tolerance will be measured by the rate and grade of chemotherapy's complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operative morbi-mortality</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average of patients who benefit from the overall treatment strategy</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>emotional status</measure>
    <time_frame>2 years</time_frame>
    <description>It will be assessed by quality of life questionnaire(QLQ-C30, QLQ-STO-22,SF-36) and emotional status questionnaire(CES-D, STAI-Y-A, Brief-IPQ, WCC, ICEC-R, CRA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">314</enrollment>
  <condition>Signet Ring Cell Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>peri-operative chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neoadjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5 fluoro-uracil (oral or intra-veinous) Surgery within 3 and 6 weeks after the end of neoadjuvant chemotherapy Adjuvant chemotherapy with 3 cycles of the same chemotherapy within 6 and 12 weeks after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery first with adjuvant chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>peri-operative chemotherapy</intervention_name>
    <description>Usual treatment strategy for gastric adenocarcinoma</description>
    <arm_group_label>peri-operative chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery first</intervention_name>
    <description>strategy with a surgical procedure first, without the usual peri-operative chemotherapy</description>
    <arm_group_label>surgery first with adjuvant chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert&#xD;
             classification,histologically proven with the presence of signet ring cells (according&#xD;
             to WHO 2000 classification) or diffuse form (according to Lauren classification) on&#xD;
             pre-therapeutic biopsies&#xD;
&#xD;
          -  tumoural stage IB, II or III (according to UICC-AJCC 2009)&#xD;
&#xD;
          -  patient judged resectable in a curative intent on inclusion&#xD;
&#xD;
          -  absence of distant metastasis&#xD;
&#xD;
          -  absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy&#xD;
&#xD;
          -  WHO performance status 2 or less&#xD;
&#xD;
          -  age over 18 or under 80 years&#xD;
&#xD;
          -  weight loss at the time of inclusion &lt; 15%&#xD;
&#xD;
          -  neutrophilic polynuclears more than 1500/mm3&#xD;
&#xD;
          -  platelets more than 100000/mm3&#xD;
&#xD;
          -  creatinine clearance more than 50 ml/min&#xD;
&#xD;
          -  serum-albumin more than 30 gram/l&#xD;
&#xD;
          -  bilirubin less than 1,5 normal&#xD;
&#xD;
          -  prothrombin rate over 80%&#xD;
&#xD;
          -  absence of prior treatment with chemotherapy or radiotherapy for gastric cancer&#xD;
&#xD;
          -  absence of kniwn child B or C cirrhosis&#xD;
&#xD;
          -  left ventricular ejection fraction more than 50% before epirubicin treatment&#xD;
&#xD;
          -  extension check-up performed within 4 weeks of inclusion&#xD;
&#xD;
          -  signed written informed consent given by the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no corresponding to the inclusion criteria&#xD;
&#xD;
          -  another malignant tumour treated for curative purposes during the past 5 years&#xD;
             excepted basocellular skin carcinoma or in situ uterine cervix cancer&#xD;
&#xD;
          -  allergy to the active substance or one of the excipients in the study drugs&#xD;
&#xD;
          -  pregnancy or breast-feeding&#xD;
&#xD;
          -  any other concommitant treatment, immunotherapy or hormonal therapy&#xD;
&#xD;
          -  history of abdominal or chest radiotherapy&#xD;
&#xD;
          -  any evolving disorder which is not under control (liver failure, kidney failure,&#xD;
             respiratory failure, evolving heart failure or myocardial necrosis during the past 6&#xD;
             months)&#xD;
&#xD;
          -  patients who cannot be regularly monitored&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume mariette, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FFCD, FNCLCC, FRENCH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guillaume Piessen, MD,PhD</last_name>
    <phone>+33320444407</phone>
    <email>guillaume.piessen@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>General and digestive surgical department, Claude Huriez Hospital, University Hospital</name>
      <address>
        <city>Lille cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>christophe mariette, MD,PhD</last_name>
      <phone>+33320444407</phone>
      <email>christophe.mariette@chru-lille.fr</email>
    </contact>
    <investigator>
      <last_name>christophe mariette</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Signet ring cell</keyword>
  <keyword>gastric adenocarcinoma</keyword>
  <keyword>peri-operative chemotherapy</keyword>
  <keyword>surgery</keyword>
  <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/NCT01717924
org study id: 2011_25
secondary id: 2012-000998-24
nct id: NCT01717924
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled
      trial comparing primary surgery versus primary chemotherapy followed by surgery in patients
      with a resectable signet ring cell gastric adenocarcinoma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients dead in the 2-years
time frame: 2 years
measure: Disease-free survival at 2 years
time frame: 2 years
measure: Disease-free survival at 3 years
time frame: 3 years
measure: Overall survival at 3 years
time frame: 3 years
measure: R0 resection rate
time frame: within 1 year
measure: grade III/IV toxicity
time frame: 2 years
description: tolerance will be measured by the rate and grade of chemotherapy's complications
measure: post operative morbi-mortality
time frame: 2 years
measure: Average of patients who benefit from the overall treatment strategy
time frame: 2 years
measure: quality of life
time frame: 2 years
measure: emotional status
time frame: 2 years
description: It will be assessed by quality of life questionnaire(QLQ-C30, QLQ-STO-22,SF-36) and emotional status questionnaire(CES-D, STAI-Y-A, Brief-IPQ, WCC, ICEC-R, CRA)
arm group label: peri-operative chemotherapy
arm group type: Active Comparator
description: Neoadjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5 fluoro-uracil (oral or intra-veinous) Surgery within 3 and 6 weeks after the end of neoadjuvant chemotherapy Adjuvant chemotherapy with 3 cycles of the same chemotherapy within 6 and 12 weeks after surgery
arm group label: surgery first with adjuvant chemotherapy
arm group type: Experimental
description: Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy
intervention type: Procedure
intervention name: peri-operative chemotherapy
description: Usual treatment strategy for gastric adenocarcinoma
arm group label: peri-operative chemotherapy
intervention type: Procedure
intervention name: Surgery first
description: strategy with a surgical procedure first, without the usual peri-operative chemotherapy
arm group label: surgery first with adjuvant chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guillaume mariette, MD,PhD
role: Principal Investigator
affiliation: FFCD, FNCLCC, FRENCH
last name: Guillaume Piessen, MD,PhD
phone: +33320444407
email: guillaume.piessen@chru-lille.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma