<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/NCT02191566</url>
  </required_header>
  <id_info>
    <org_study_id>SOHUG</org_study_id>
    <nct_id>NCT02191566</nct_id>
  </id_info>
  <brief_title>S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy</brief_title>
  <acronym>SOHUG</acronym>
  <official_title>A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kangbuk Samsung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kangbuk Samsung Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given&#xD;
      chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and&#xD;
      oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was&#xD;
      administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The patient's study enrollment was too low.&#xD;
  </why_stopped>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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>3-year recurrence-free survival, RFS</measure>
    <time_frame>3-year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-year overall survival, OS</measure>
    <time_frame>5-year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Toxicity will be graded according to the CTCAE.</measure>
    <time_frame>1-year</time_frame>
    <description>For patients who have experienced a dosing delay for starting treatment cycle, all assessments will be performed as scheduled. Reasons for dose modifications or delays, the supportive measures taken, and the outcome will be documented in the patient's chart and recorded in the CRF.</description>
  </other_outcome>
  <other_outcome>
    <measure>compliance for chemotherapy</measure>
    <time_frame>1-year</time_frame>
    <description>Accountability and subject compliance will be assessed by maintaining adequate dose of S1 and return records. Subjects will be asked to return all used and unused drug supply containers at the end of each cycle as a measure of compliance. The clinical administration records will be used to monitor compliance with oxaliplatin.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Stomach Cancer</condition>
  <arm_group>
    <arm_group_label>S-1/Oxaliplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1 (452500ACH)</intervention_name>
    <description>S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months</description>
    <arm_group_label>S-1/Oxaliplatin</arm_group_label>
    <other_name>TS-1 (tegafur+gimeracil+oteracil)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OXALIPLATIN (205803BIJ)</intervention_name>
    <description>Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months</description>
    <arm_group_label>S-1/Oxaliplatin</arm_group_label>
    <other_name>PLEOXTIN (645402430)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who voluntarily provide written informed consent prior to entering into this&#xD;
             study&#xD;
&#xD;
          -  Newly definitely diagnosed with primary gastric or gastroesophageal junction&#xD;
             adenocarcinoma histologically&#xD;
&#xD;
          -  Patients who underwent radical resection with wide lymph node dissection&#xD;
&#xD;
          -  TNM stage (6th AJCC) of IIIB or IV on post-operative staging&#xD;
&#xD;
          -  Patients who can be randomized within 6 weeks after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &lt; 20 years or ≥ 76 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &gt;2&#xD;
&#xD;
          -  Patients who underwent surgery for neoplasm in stomach in the past&#xD;
&#xD;
          -  History of malignant disease The following cases can be included in this study -&#xD;
             adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ&#xD;
&#xD;
          -  Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1)&#xD;
             including distant lymph node (behind the pancreas, along the aorta, portal vein,&#xD;
             behind the peritoneum, mesenteric lymph node)&#xD;
&#xD;
          -  Residual cancer on post-operative staging (R1 and R2 resection)&#xD;
&#xD;
          -  Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or&#xD;
             radiotherapy and/or immunotherapy in the past for treatment of gastric cancer&#xD;
&#xD;
          -  Any of the following within 6 months prior to the study recruitment: Myocardial&#xD;
             infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III&#xD;
             or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac&#xD;
             arrhythmia requiring treatment&#xD;
&#xD;
          -  Patients of childbearing potential who do not agree to use generally accepted&#xD;
             effective method of birth control during the study treatment period and for at least 6&#xD;
             months after the end of study treatment&#xD;
&#xD;
          -  Pregnant women, breastfeeding women, or women of childbearing potential whose&#xD;
             pregnancy test result is positive•&#xD;
&#xD;
          -  History of hypersensitivity to the investigational products (S1 and Oxaliplatin)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong Hoe Koo, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kangbuk Samsung Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-746</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.</citation>
    <PMID>22010012</PMID>
  </reference>
  <reference>
    <citation>Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.</citation>
    <PMID>22226517</PMID>
  </reference>
  <reference>
    <citation>Lee SS, Jeung HC, Chung HC, Noh SH, Hyung WJ, Ahn JY, Rha SY. A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. Invest New Drugs. 2012 Feb;30(1):357-63. doi: 10.1007/s10637-010-9515-2. Epub 2010 Aug 24.</citation>
    <PMID>20734110</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kangbuk Samsung Hospital</investigator_affiliation>
    <investigator_full_name>Dong-Hoe Koo</investigator_full_name>
    <investigator_title>Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Stomach Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Tegafur</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/NCT02191566
org study id: SOHUG
nct id: NCT02191566
lead sponsor: 
has dmc: No
After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given
      chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and
      oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was
      administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year recurrence-free survival, RFS
time frame: 3-year
measure: 5-year overall survival, OS
time frame: 5-year
measure: Toxicity will be graded according to the CTCAE.
time frame: 1-year
description: For patients who have experienced a dosing delay for starting treatment cycle, all assessments will be performed as scheduled. Reasons for dose modifications or delays, the supportive measures taken, and the outcome will be documented in the patient's chart and recorded in the CRF.
measure: compliance for chemotherapy
time frame: 1-year
description: Accountability and subject compliance will be assessed by maintaining adequate dose of S1 and return records. Subjects will be asked to return all used and unused drug supply containers at the end of each cycle as a measure of compliance. The clinical administration records will be used to monitor compliance with oxaliplatin.
arm group label: S-1/Oxaliplatin
arm group type: Experimental
description: S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
intervention type: Drug
intervention name: S-1 (452500ACH)
description: S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
arm group label: S-1/Oxaliplatin
other name: TS-1 (tegafur+gimeracil+oteracil)
intervention type: Drug
intervention name: OXALIPLATIN (205803BIJ)
description: Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
arm group label: S-1/Oxaliplatin
other name: PLEOXTIN (645402430)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dong Hoe Koo, MD,PhD
role: Principal Investigator
affiliation: Kangbuk Samsung Hospital
facility: 
country: Korea, Republic of
citation: Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.
PMID: 22010012
citation: Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
PMID: 22226517
citation: Lee SS, Jeung HC, Chung HC, Noh SH, Hyung WJ, Ahn JY, Rha SY. A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. Invest New Drugs. 2012 Feb;30(1):357-63. doi: 10.1007/s10637-010-9515-2. Epub 2010 Aug 24.
PMID: 20734110
responsible party type: Principal Investigator
investigator affiliation: Kangbuk Samsung Hospital
investigator full name: Dong-Hoe Koo
investigator title: Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine
mesh term: Stomach Neoplasms
mesh term: Oxaliplatin
mesh term: Tegafur