<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/NCT02192983</url>
  </required_header>
  <id_info>
    <org_study_id>zswy002</org_study_id>
    <nct_id>NCT02192983</nct_id>
  </id_info>
  <brief_title>A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer.</brief_title>
  <official_title>A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianshu Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess what is the better neoadjuvant chemotherapy regimen for&#xD;
      patients with initially unresectable locally advanced gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Response rate</measure>
    <time_frame>6 months after diagnosis</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">242</enrollment>
  <condition>Locally Advanced Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>chemotherapy regimen</arm_group_label>
    <description>those with XELOX regimen and those with EOX regimen</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        242&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 2 regional bulky lymph nodes macroscopic tumor type is either the Borrmann&#xD;
             type 4 or large type 3 tumor invades adjacent structures (T4b)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  peritoneal metastasis confirmed by CT scan lung metastasis, liver metastasis, pleural&#xD;
             effusion, and/or other distant metastasis&#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>tianshu liu</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Zhongshan Ethics Committee</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Tianshu Liu</investigator_full_name>
    <investigator_title>Chairman of the department of oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</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/NCT02192983
org study id: zswy002
nct id: NCT02192983
lead sponsor: 
has dmc: No
This study is designed to assess what is the better neoadjuvant chemotherapy regimen for
      patients with initially unresectable locally advanced gastric cancer.
observational model: Cohort
time perspective: Prospective
measure: Response rate
time frame: 6 months after diagnosis
arm group label: chemotherapy regimen
description: those with XELOX regimen and those with EOX regimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: tianshu liu
role: Study Chair
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Tianshu Liu
investigator title: Chairman of the department of oncology
mesh term: Stomach Neoplasms