<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/NCT03814759</url>
  </required_header>
  <id_info>
    <org_study_id>4-2015-0603</org_study_id>
    <nct_id>NCT03814759</nct_id>
  </id_info>
  <brief_title>Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma</brief_title>
  <official_title>Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A&#xD;
      cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric&#xD;
      cancer excluding early gastric cancer is about 40 ~ 67%. Therefore, several methods for&#xD;
      lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be&#xD;
      considered as a method to lower the recurrence rate of gastric cancer. The purpose of this&#xD;
      study is to evaluate the pathologic response rate and safety of patients who underwent&#xD;
      surgery after chemoradiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Anticipated">July 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pathological response rate</measure>
    <time_frame>10 week</time_frame>
    <description>to evaluate pathological response rate in locally advanced resectable gastric cancer</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>SP+CCRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TS-1 + cisplatin</intervention_name>
    <description>S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)</description>
    <arm_group_label>SP+CCRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiation</intervention_name>
    <description>radiation 45Gy per 5 weeks</description>
    <arm_group_label>SP+CCRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 20 years old&#xD;
&#xD;
          2. Histologically confirmed gastric adenocarcinoma&#xD;
&#xD;
          3. clinical stage : resectable gastric cancer&#xD;
&#xD;
               -  advanced confirmed (EGD)&#xD;
&#xD;
               -  extramural infiltration&gt; 1 mm (CT)&#xD;
&#xD;
               -  positive serosa invasion (EUS)&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status 0 or 1&#xD;
&#xD;
          5. no prior chemotherapy and radiotherapy&#xD;
&#xD;
          6. measurable lesion or evaluable lesion according to Response Evaluation Criteria in&#xD;
             Solid Tumors version 1.1 criteria&#xD;
&#xD;
          7. Patients with adequate organ function&#xD;
&#xD;
          8. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metastasis esophageal invasion &gt; 3cm&#xD;
&#xD;
          2. inoperable peritoneal seeding disease determined by exploratory laparotomy&#xD;
&#xD;
          3. T4b invading the surrounding organs&#xD;
&#xD;
          4. lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node&#xD;
&#xD;
          5. uncontrolled viral infections (HIV, HBV, HCV)&#xD;
&#xD;
          6. Pregnant or lactating women, women of childbearing potential not employing adequate&#xD;
             contraception&#xD;
&#xD;
          7. severe hypersensitivity reactions to S-1, cisplatin&#xD;
&#xD;
          8. Subjects with uncontrolled clinically significant cardiovascular medical history,&#xD;
             uncontrolled infection or complication&#xD;
&#xD;
          9. Other co-existing malignancies or malignancies diagnosed within the last 5 years&#xD;
             except for curatively treated non-melanoma skin cancer or in situ carcinoma of the&#xD;
             cervix&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyo Song Kim</last_name>
    <phone>82-2-2228-8124</phone>
    <email>hyosong77@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyo Song Kim</last_name>
      <phone>82-2-2228-8124</phone>
      <email>hyosong77@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Hyo Song Kim</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>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</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/NCT03814759
org study id: 4-2015-0603
nct id: NCT03814759
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A
      cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric
      cancer excluding early gastric cancer is about 40 ~ 67%. Therefore, several methods for
      lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be
      considered as a method to lower the recurrence rate of gastric cancer. The purpose of this
      study is to evaluate the pathologic response rate and safety of patients who underwent
      surgery after chemoradiotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pathological response rate
time frame: 10 week
description: to evaluate pathological response rate in locally advanced resectable gastric cancer
arm group label: SP+CCRT
arm group type: Experimental
description: S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
intervention type: Drug
intervention name: TS-1 + cisplatin
description: S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)
arm group label: SP+CCRT
intervention type: Radiation
intervention name: radiation
description: radiation 45Gy per 5 weeks
arm group label: SP+CCRT
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hyo Song Kim
phone: 82-2-2228-8124
email: hyosong77@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Hyo Song Kim
investigator title: professor
mesh term: Adenocarcinoma
mesh term: Cisplatin