<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/NCT03237507</url>
  </required_header>
  <id_info>
    <org_study_id>TOTPMSG1602</org_study_id>
    <nct_id>NCT03237507</nct_id>
  </id_info>
  <brief_title>Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer</brief_title>
  <official_title>Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbin Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-interventional study，aim to observe the safety and efficiency of different&#xD;
      treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>PFS: Progression Free Survival</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>time from enrollment to disease progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS:overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>time from enrollment to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>3 years</time_frame>
    <description>measured by recording the subjects' Adverse Events according to CTCAE 4.03</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Stage IV Gastric Cancer With Metastasis</condition>
  <arm_group>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <description>chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy plus HIPEC Group</arm_group_label>
    <description>Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1</intervention_name>
    <description>40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.</description>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_label>Chemotherapy plus HIPEC Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxaliplatin</intervention_name>
    <description>100mg/m^2 days 1，intravenous infusion, every 3 weeks.</description>
    <arm_group_label>Chemotherapy Group</arm_group_label>
    <arm_group_label>Chemotherapy plus HIPEC Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hyperthermic Intraperitoneal</intervention_name>
    <description>hyperthermic intraperitoneal chemoperfusion</description>
    <arm_group_label>Chemotherapy plus HIPEC Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>intraperitoneal perfusion</description>
    <arm_group_label>Chemotherapy plus HIPEC Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with histologically confirmed gastric cancer or gastroesophageal junction&#xD;
        adenocarcinoma, stage IV with peritoneal metastasis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 ≤ age&#xD;
&#xD;
          -  Patients with histologically confirmed gastric cancer or gastroesophageal junction&#xD;
             adenocarcinoma, stage IV with peritoneal metastasis&#xD;
&#xD;
          -  Didn't received any prior systemic chemotherapy&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil&#xD;
             Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product&#xD;
&#xD;
          -  Pregnancy or lactation women,&#xD;
&#xD;
          -  Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3&#xD;
&#xD;
          -  Inadequate organ function which is defined as below:&#xD;
&#xD;
        Total bilirubin &gt;2 pper limit of normal range (ULN); ALT / AST &gt; 2.5 upper limit of normal&#xD;
        range (ULN); serum creatinine &gt; 1.5 mg/dL, and Ccr &gt; 60 ml/min (estimated by&#xD;
        Cockcroft-Gault formulation);&#xD;
&#xD;
          -  Symptomatic peripheral neuropathy&#xD;
&#xD;
          -  Receiving a concomitant treatment with other fluoropyrimidines&#xD;
&#xD;
          -  Fluoropyrimidines (DPD) congenital absence&#xD;
&#xD;
          -  Other Situations which physicians suggesting are inadaptable for enrollment&#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>Kuan Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Wang Kuan, M.D.Prof</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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>Paclitaxel</mesh_term>
    <mesh_term>Oxaliplatin</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/NCT03237507
org study id: TOTPMSG1602
nct id: NCT03237507
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a non-interventional study，aim to observe the safety and efficiency of different
      treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world
observational model: Cohort
time perspective: Prospective
measure: PFS: Progression Free Survival
time frame: through study completion, an average of 1 year
description: time from enrollment to disease progression or death
measure: OS:overall survival
time frame: 3 years
description: time from enrollment to death
measure: Safety
time frame: 3 years
description: measured by recording the subjects' Adverse Events according to CTCAE 4.03
arm group label: Chemotherapy Group
description: chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
arm group label: Chemotherapy plus HIPEC Group
description: Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
intervention type: Drug
intervention name: S-1
description: 40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.
arm group label: Chemotherapy Group
arm group label: Chemotherapy plus HIPEC Group
intervention type: Drug
intervention name: oxaliplatin
description: 100mg/m^2 days 1，intravenous infusion, every 3 weeks.
arm group label: Chemotherapy Group
arm group label: Chemotherapy plus HIPEC Group
intervention type: Device
intervention name: Hyperthermic Intraperitoneal
description: hyperthermic intraperitoneal chemoperfusion
arm group label: Chemotherapy plus HIPEC Group
intervention type: Drug
intervention name: Paclitaxel
description: intraperitoneal perfusion
arm group label: Chemotherapy plus HIPEC Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kuan Wang
role: Principal Investigator
affiliation: Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Harbin Medical University
investigator full name: Wang Kuan, M.D.Prof
investigator title: Professor
mesh term: Neoplasm Metastasis
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Oxaliplatin