<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/NCT02205047</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1203-GITCG</org_study_id>
    <secondary_id>2014-000722-38</secondary_id>
    <secondary_id>MO28922</secondary_id>
    <nct_id>NCT02205047</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma</brief_title>
  <acronym>INNOVATION</acronym>
  <official_title>INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out whether either trastuzumab or the combination of&#xD;
      trastuzumab and pertuzumab with standard chemotherapy shows more activity against&#xD;
      gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery&#xD;
      and it can be safely administered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized phase II trial with an internal control. The randomization will be a&#xD;
      1:2:2 randomization (control: experimental arm 1: experimental arm 2). Potentially eligible&#xD;
      patients will be screened centrally for the HER-2 status. After confirmation of HER-2&#xD;
      positive disease, eligible patients will be centrally randomized through the EORTC&#xD;
      randomization system. A minimization technique will be used for random treatment allocation&#xD;
      between the three treatment arms. Stratification will be done by histological subtype&#xD;
      (intestinal/non-intestinal); Korea versus Europe; stage II versus III; node positive versus&#xD;
      node negative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 15, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Actual">December 22, 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>Near Complete Pathological Response Rate</measure>
    <time_frame>After 3 cycles (21 days) of neoadjuvant chemotherapy</time_frame>
    <description>To increase the major pathological response rate (&lt; 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Locoregional failure</measure>
    <time_frame>At the time of surgery and at 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>At the time of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant failure</measure>
    <time_frame>At the time of surgery and at 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>5 years after LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival</measure>
    <time_frame>5 years after LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years after LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>5 years after LPI</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">171</enrollment>
  <condition>Malignant Neoplasm of Stomach</condition>
  <condition>Malignant Neoplasm of Cardio-esophageal Junction of Stomach</condition>
  <condition>Epidermal Growth Factor Receptor (EGFR) Protein Overexpression</condition>
  <arm_group>
    <arm_group_label>Standard chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cisplatin/capecitabine or cisplatin/5-fluorouracil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_label>Experimental arm 2</arm_group_label>
    <arm_group_label>Standard chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-fluorouracil or Capecitabine</intervention_name>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_label>Experimental arm 2</arm_group_label>
    <arm_group_label>Standard chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_label>Experimental arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pertuzumab</intervention_name>
    <arm_group_label>Experimental arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gastrectomy</intervention_name>
    <description>D2 gastrectomy</description>
    <arm_group_label>Experimental arm 1</arm_group_label>
    <arm_group_label>Experimental arm 2</arm_group_label>
    <arm_group_label>Standard chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven, gastric or gastroesophageal (GE)-junction adenocarcinoma&#xD;
             (Siewert I-III)&#xD;
&#xD;
          -  Patient medically fit for gastrectomy/oesophagogastrectomy as decided by the&#xD;
             investigator&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  WHO performance status 0 - 1&#xD;
&#xD;
          -  HER-2 overexpression&#xD;
&#xD;
          -  Amenable to gastrectomy/oesophagectomy&#xD;
&#xD;
          -  The cardiac ejection fraction (LVEF), as determined by echocardiography, multiple&#xD;
             gated acquisition scan (MUGA) or cardiac MRI should be at least 50 %&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  For women who are not postmenopausal (&gt; 12 months of non-therapy induced amenorrhea)&#xD;
             or surgically sterile (absence of ovaries and/or uterus): agreement to remain&#xD;
             abstinent or use single or combined contraceptive methods that result in a failure&#xD;
             rate of &lt; 1% per year during the treatment period and for at least 12 months after the&#xD;
             last treatment dose&#xD;
&#xD;
          -  For men: agreement to remain abstinent or use a condom plus an additional&#xD;
             contraceptive method that together result in a failure rate of &lt; 1% per year during&#xD;
             the treatment period and for at least 12 months after the last dose of study&#xD;
             treatment. Abstinence is only acceptable if it is in line with the preferred and usual&#xD;
             lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation,&#xD;
             symptothermal, or postovulation methods) and withdrawal are not acceptable methods for&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of distant metastases on CT scan of thorax and abdomen&#xD;
&#xD;
          -  prior chemo- or antibody therapy&#xD;
&#xD;
          -  history of significant cardiac disease&#xD;
&#xD;
          -  current uncontrolled hypertension&#xD;
&#xD;
          -  known hypersensitivity to the components of trastuzumab, pertuzumab, cisplatin,&#xD;
             5-follow-up or capecitabine&#xD;
&#xD;
          -  known dihydropyrimidine dehydrogenase (DPD) deficiency&#xD;
&#xD;
          -  ongoing or concomitant use of the antiviral drug sorivudine or its chemically related&#xD;
             analogs, such as brivudine&#xD;
&#xD;
          -  chronic treatment with high-dose intravenous corticosteroids&#xD;
&#xD;
          -  previous malignancy within the last 5 years, with the exception of adequately treated&#xD;
             cervical carcinoma in situ, localized non-melanoma skin cancer, or other curatively&#xD;
             treated cancer without impact on the patient's overall prognosis according to the&#xD;
             judgment of the investigator.&#xD;
&#xD;
          -  psychological, familial, sociological or geographical condition potentially hampering&#xD;
             compliance with the study protocol and follow-up schedule&#xD;
&#xD;
          -  pregnant or 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_official>
    <last_name>Anna Dorothea Wagner, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre hospitalier universitaire vaudois, Lausanne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Gent</name>
      <address>
        <city>Gent</city>
        <state>Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonia Medical Centre</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Besancon - Hopital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille - Hopital Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims - Hôpital Robert Debré</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Essen-Mitte - Evang. Huyssens-Stiftung</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin Goettingen - Georg-August Universitaet</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Kliniken GmbH - Asklepios Klinik Barmbek</name>
      <address>
        <city>Hamburg</city>
        <zip>22291</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SLK-Kliniken Heilbronn GmbH</name>
      <address>
        <city>Heilbronn</city>
        <zip>74078</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologische Unter-Ems (Leer-Papenburg-Emden)</name>
      <address>
        <city>Leer</city>
        <zip>26789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center</name>
      <address>
        <city>Mainz</city>
        <zip>55101</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universitaet München - Campus Grosshadern</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Technische Universität München - Klinikum Rechts der Isar</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>135-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>14068</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital YUCM</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea-St. Vincent's Hospital</name>
      <address>
        <city>Suwon-Si Gyeonggi-do</city>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital - Radiumhospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues De Oncologia - Centro Do Porto</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d'Oncologia - ICO L'Hospitalet</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Badalona (Institut Catala d'Oncologia) - Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron - Institut Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia)</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario De Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève - HUG</name>
      <address>
        <city>Geneve</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - site: London Chelsea</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals (UCLH) - NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - site: Sutton, Surrey</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Portugal</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
  </removed_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neoadjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Pertuzumab</mesh_term>
  </intervention_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/NCT02205047
org study id: EORTC-1203-GITCG
secondary id: 2014-000722-38
secondary id: MO28922
nct id: NCT02205047
lead sponsor: 
has dmc: Yes
The purpose of this study is to find out whether either trastuzumab or the combination of
      trastuzumab and pertuzumab with standard chemotherapy shows more activity against
      gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery
      and it can be safely administered.
This is a randomized phase II trial with an internal control. The randomization will be a
      1:2:2 randomization (control: experimental arm 1: experimental arm 2). Potentially eligible
      patients will be screened centrally for the HER-2 status. After confirmation of HER-2
      positive disease, eligible patients will be centrally randomized through the EORTC
      randomization system. A minimization technique will be used for random treatment allocation
      between the three treatment arms. Stratification will be done by histological subtype
      (intestinal/non-intestinal); Korea versus Europe; stage II versus III; node positive versus
      node negative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Near Complete Pathological Response Rate
time frame: After 3 cycles (21 days) of neoadjuvant chemotherapy
description: To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
measure: Locoregional failure
time frame: At the time of surgery and at 5 years
measure: R0 resection rate
time frame: At the time of surgery
measure: Distant failure
time frame: At the time of surgery and at 5 years
measure: Progression-free survival
time frame: 5 years after LPI
measure: Recurrence-free survival
time frame: 5 years after LPI
measure: Overall survival
time frame: 5 years after LPI
measure: Toxicity
time frame: 5 years after LPI
arm group label: Standard chemotherapy
arm group type: Active Comparator
description: Cisplatin/capecitabine or cisplatin/5-fluorouracil
arm group label: Experimental arm 1
arm group type: Experimental
description: Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab
arm group label: Experimental arm 2
arm group type: Experimental
description: cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab
intervention type: Drug
intervention name: Cisplatin
arm group label: Experimental arm 1
arm group label: Experimental arm 2
arm group label: Standard chemotherapy
intervention type: Drug
intervention name: 5-fluorouracil or Capecitabine
arm group label: Experimental arm 1
arm group label: Experimental arm 2
arm group label: Standard chemotherapy
intervention type: Drug
intervention name: Trastuzumab
arm group label: Experimental arm 1
arm group label: Experimental arm 2
intervention type: Drug
intervention name: Pertuzumab
arm group label: Experimental arm 2
intervention type: Procedure
intervention name: gastrectomy
description: D2 gastrectomy
arm group label: Experimental arm 1
arm group label: Experimental arm 2
arm group label: Standard chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Dorothea Wagner, MD
role: Study Chair
affiliation: Centre hospitalier universitaire vaudois, Lausanne
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country: Belgium
country: Estonia
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Netherlands
country: Norway
country: Portugal
country: Singapore
country: Spain
country: Switzerland
country: United Kingdom
country: Israel
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Stomach Neoplasms
mesh term: Fluorouracil
mesh term: Capecitabine
mesh term: Trastuzumab
mesh term: Pertuzumab