<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/NCT02976142</url>
  </required_header>
  <id_info>
    <org_study_id>MKNC02/2016</org_study_id>
    <nct_id>NCT02976142</nct_id>
  </id_info>
  <brief_title>The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer</brief_title>
  <official_title>Prospective Randomized Phase II Clinical Trial: the Efficacy of Surgical Treatment in Combinations With Intraperitoneal Immunotherapy and Systemic Chemotherapy in Patients With Gastric Cancer and Verified Free Cancer Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moscow Clinical Scientific Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Moscow Clinical Scientific Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether intraperitoneal immunotherapy (with&#xD;
      interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more&#xD;
      effective than systemic chemotherapy alone in patients with gastric cancer and verified free&#xD;
      cancer cells in abdominal cavity in improving the long term outcomes and overall survival of&#xD;
      further surgical treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2018</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>Overall 2-year survival</measure>
    <time_frame>2 years</time_frame>
    <description>Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -&gt; M0; Cyt &quot;+&quot; -&gt; Cyt &quot;-&quot;) with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Portability of the systemic therapy methods</measure>
    <time_frame>6,9,12,24 months</time_frame>
    <description>Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>24 months</time_frame>
    <description>Mortality related to intraperitoneal immunotherapy and systemic chemotherapy It is defined as the death within 24 months from the start of the treatment regardless of the reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Downstaging tumor</measure>
    <time_frame>2 years</time_frame>
    <description>Number of patients that were downstaged (M1 -&gt; M0; Cyt &quot;+&quot; -&gt; Cyt &quot;-&quot;) with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6, 12, 18, 24 months</time_frame>
    <description>Quality of life ECOG scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Gastric Cancer, Metastatic</condition>
  <arm_group>
    <arm_group_label>neoadjuvant chemoimmunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with gastric cancer and verified free cancer cells who receive 1 course of intraperitoneal immunotherapy with interleykin-2 + 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -&gt; M0) surgical treatment will be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neoadjuvant chemotherapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with gastric cancer and verified free cancer cells who receive 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -&gt; M0) surgical treatment will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>neoadjuvant chemoimmunotherapy</intervention_name>
    <arm_group_label>neoadjuvant chemoimmunotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ECOG 0-2&#xD;
&#xD;
          -  Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer&#xD;
             cells in the abdominal cavity and no macroscopic canceromathosis and no other distant&#xD;
             metastases (TNM classification 7th edition)&#xD;
&#xD;
          -  Histological forms: gastric adenocarcinoma and signet ring cancer&#xD;
&#xD;
          -  Blood characteristics (creatinine &lt;150 mg/l, total bilirubin &lt; 50 mkmol/l, neutrophils&#xD;
             &lt; 1500/mkl, hemoglobin &gt;90 g/l, thrombocytes &gt; 100000/mkl)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically apparent distant metastasis (besides free cancer cells)&#xD;
&#xD;
          -  Synchronic or metachronic malignant tumors&#xD;
&#xD;
          -  Previous systemic or surgical or combined therapy for gastric cancer&#xD;
&#xD;
          -  Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding)&#xD;
&#xD;
          -  Adhesions in abdominal cavity&#xD;
&#xD;
          -  Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.&#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>Nikolay Semenov</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moscow Clinical Scientific Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Boris Pomortsev</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moscow Clinical Scientific Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Igor Khatkov, Professor, PhD</last_name>
    <email>i.hatkov@mknc.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Roman Izrailov, Professor, PhD</last_name>
    <email>r.izrailov@mknc.ru</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric cancer, metastatic</keyword>
  <keyword>positive wash cytology</keyword>
  <keyword>neoadjuvant intraperitoneal immunotherapy</keyword>
  <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/NCT02976142
org study id: MKNC02/2016
nct id: NCT02976142
lead sponsor: 
The purpose of this study is to determine whether intraperitoneal immunotherapy (with
      interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more
      effective than systemic chemotherapy alone in patients with gastric cancer and verified free
      cancer cells in abdominal cavity in improving the long term outcomes and overall survival of
      further surgical treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall 2-year survival
time frame: 2 years
description: Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
measure: Portability of the systemic therapy methods
time frame: 6,9,12,24 months
description: Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
measure: Mortality
time frame: 24 months
description: Mortality related to intraperitoneal immunotherapy and systemic chemotherapy It is defined as the death within 24 months from the start of the treatment regardless of the reason.
measure: Downstaging tumor
time frame: 2 years
description: Number of patients that were downstaged (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
measure: Morbidity
time frame: 30 days
description: Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging)
measure: Quality of life
time frame: 6, 12, 18, 24 months
description: Quality of life ECOG scale.
arm group label: neoadjuvant chemoimmunotherapy
arm group type: Experimental
description: Patients with gastric cancer and verified free cancer cells who receive 1 course of intraperitoneal immunotherapy with interleykin-2 + 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -> M0) surgical treatment will be performed.
arm group label: neoadjuvant chemotherapy
arm group type: No Intervention
description: Patients with gastric cancer and verified free cancer cells who receive 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -> M0) surgical treatment will be performed.
intervention type: Procedure
intervention name: neoadjuvant chemoimmunotherapy
arm group label: neoadjuvant chemoimmunotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nikolay Semenov
role: Principal Investigator
affiliation: Moscow Clinical Scientific Center
last name: Boris Pomortsev
role: Principal Investigator
affiliation: Moscow Clinical Scientific Center
last name: Igor Khatkov, Professor, PhD
email: i.hatkov@mknc.ru
last name: Roman Izrailov, Professor, PhD
email: r.izrailov@mknc.ru
responsible party type: Sponsor
mesh term: Stomach Neoplasms