<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/NCT02240524</url>
  </required_header>
  <id_info>
    <org_study_id>2014514</org_study_id>
    <nct_id>NCT02240524</nct_id>
  </id_info>
  <brief_title>Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer</brief_title>
  <acronym>HIPEC</acronym>
  <official_title>A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to study the efficacy of hyperthermic intraperitoneal&#xD;
      chemotherapy in the treatment of patients with locally advanced gastric cancer after radical&#xD;
      gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>Phase 3</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>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>From the date of surgery to the date of death or to the end of follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>From the date of surgery to the date of recurrence or to the end of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>From the date of surgery to the date of locoregional recurrence or to the end of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic metastases-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>From the date of surgery to the date of recurrence or to the end of follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">582</enrollment>
  <condition>Advanced Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>D2 lymphadenectomy and HIPEC and Systemic chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy.&#xD;
HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min.&#xD;
Systemic chemotherapy (XELOX):&#xD;
Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D2 lymphadenectomy+Systemic chemotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy.&#xD;
Systemic chemotherapy (XELOX):&#xD;
Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>D2 lymphadenectomy</intervention_name>
    <description>The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.</description>
    <arm_group_label>D2 lymphadenectomy and HIPEC and Systemic chemotherapy</arm_group_label>
    <arm_group_label>D2 lymphadenectomy+Systemic chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Systemic chemotherapy</intervention_name>
    <arm_group_label>D2 lymphadenectomy and HIPEC and Systemic chemotherapy</arm_group_label>
    <arm_group_label>D2 lymphadenectomy+Systemic chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HIPEC</intervention_name>
    <arm_group_label>D2 lymphadenectomy and HIPEC and Systemic chemotherapy</arm_group_label>
    <other_name>hyperthermic intraperitoneal chemoperfusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 &lt; age ≤ 65 years old&#xD;
&#xD;
          -  Male or Non pregnant female&#xD;
&#xD;
          -  The Eastern Cooperative Oncology Group (ECOG) status ≤ 2&#xD;
&#xD;
          -  Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained&#xD;
             by endoscopic ultrasound or CT scan)&#xD;
&#xD;
          -  Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy&#xD;
&#xD;
          -  White blood cells &gt; 4,000/mm3&#xD;
&#xD;
          -  neutrophils ≥ 1,500/mm3&#xD;
&#xD;
          -  platelets ≥ 100,000/mm3&#xD;
&#xD;
          -  hemoglobin&gt;9g/l&#xD;
&#xD;
          -  Alanine transaminase (ALT) and aspartate aminotransferase (AST) &lt; or = 2.5 times upper&#xD;
             limit of nominal (ULN)&#xD;
&#xD;
          -  total bilirubin (TBIL) &lt; 1.5 times ULN&#xD;
&#xD;
          -  serum creatinine &lt; 1 times ULN&#xD;
&#xD;
          -  Having given written informed consent prior to any procedure related to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existence of macroscopic peritoneal implants&#xD;
&#xD;
          -  Prior malignant tumors with detectable signs of recurrence or distant metastasis&#xD;
&#xD;
          -  Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac&#xD;
             insufficiency, persistent hypertension despite medicinal treatment, ejection&#xD;
             fraction&lt;50%&#xD;
&#xD;
          -  Receiving other cytotoxic chemotherapy&#xD;
&#xD;
          -  High grade of intra-abdominal adhesions&#xD;
&#xD;
          -  Contraindication to any therapy contained in this regimen specific to the study&#xD;
             Without given written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>shuzhong cui, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zhiyuan fang, Ph.D</last_name>
    <phone>86020666736662012</phone>
    <email>fangjnu@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510095</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhiyuan fang, Ph.D</last_name>
      <phone>86020666736662012</phone>
      <email>fangjnu@gmail.com</email>
    </contact>
    <investigator>
      <last_name>shuzhong cui, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>June 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric adenocarcinoma</keyword>
  <keyword>HIPEC</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Capecitabine</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/NCT02240524
org study id: 2014514
nct id: NCT02240524
lead sponsor: 
has dmc: Yes
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal
      chemotherapy in the treatment of patients with locally advanced gastric cancer after radical
      gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 5 years
description: From the date of surgery to the date of death or to the end of follow-up
measure: Recurrence-free survival
time frame: 5 years
description: From the date of surgery to the date of recurrence or to the end of follow-up
measure: Locoregional-free survival
time frame: 5 years
description: From the date of surgery to the date of locoregional recurrence or to the end of follow-up
measure: Hepatic metastases-free survival
time frame: 5 years
description: From the date of surgery to the date of recurrence or to the end of follow-up
arm group label: D2 lymphadenectomy and HIPEC and Systemic chemotherapy
arm group type: Experimental
description: Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy.
HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min.
Systemic chemotherapy (XELOX):
Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.
arm group label: D2 lymphadenectomy+Systemic chemotherapy
arm group type: Placebo Comparator
description: 8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy.
Systemic chemotherapy (XELOX):
Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.
intervention type: Procedure
intervention name: D2 lymphadenectomy
description: The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
arm group label: D2 lymphadenectomy and HIPEC and Systemic chemotherapy
arm group label: D2 lymphadenectomy+Systemic chemotherapy
intervention type: Procedure
intervention name: Systemic chemotherapy
arm group label: D2 lymphadenectomy and HIPEC and Systemic chemotherapy
arm group label: D2 lymphadenectomy+Systemic chemotherapy
intervention type: Procedure
intervention name: HIPEC
arm group label: D2 lymphadenectomy and HIPEC and Systemic chemotherapy
other name: hyperthermic intraperitoneal chemoperfusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: shuzhong cui, Ph.D
role: Study Director
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
last name: zhiyuan fang, Ph.D
phone: 86020666736662012
email: fangjnu@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma