<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/NCT01671449</url>
  </required_header>
  <id_info>
    <org_study_id>AMC-ONCGI-1202</org_study_id>
    <nct_id>NCT01671449</nct_id>
  </id_info>
  <brief_title>S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer</brief_title>
  <acronym>SOPP</acronym>
  <official_title>Phase III Trial of S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Min-Hee Ryu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly)&#xD;
      versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric&#xD;
      cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Progression-free survival</measure>
    <time_frame>From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years</time_frame>
    <description>The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of randomization to death from any cause, assessed up to 3 years</time_frame>
    <description>Overall survival is defined as the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>Every 6 weeks</time_frame>
    <description>Response assessment will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 every 2 cycles (6 weeks) of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Every 6 weeks</time_frame>
    <description>Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>Every 3 weeks</time_frame>
    <description>Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">338</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>S-1 plus Cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)&#xD;
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.&#xD;
Cisplatin: 60 mg/ m2/day, i.v., day 1&#xD;
Every 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S-1 plus Oxaliplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)&#xD;
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.&#xD;
Oxaliplatin: 130 mg/ m2/day, i.v., day 1&#xD;
Every 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1</intervention_name>
    <description>S-1 : 40 mg/m2, twice daily, Day 1-14</description>
    <arm_group_label>S-1 plus Cisplatin</arm_group_label>
    <arm_group_label>S-1 plus Oxaliplatin</arm_group_label>
    <other_name>TS-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>60 mg/m2/day Day 1</description>
    <arm_group_label>S-1 plus Cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>130 mg/m2/day Day 1</description>
    <arm_group_label>S-1 plus Oxaliplatin</arm_group_label>
    <other_name>Pleoxin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent before the enrollment&#xD;
&#xD;
          2. Age ≥18 years old&#xD;
&#xD;
          3. Histologically/cytologically confirmed recurrent or metastatic gastric or&#xD;
             esophagogastric junctional adenocarcinoma&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          5. Patients able to swallow food and drugs&#xD;
&#xD;
          6. At least one measurable or evaluable lesion according to RECIST criteria version 1.1&#xD;
&#xD;
          7. Adequate bone, hepatic, and renal function as assessed by the following laboratory&#xD;
             requirements to be conducted within 7 days prior to first administration of study&#xD;
             drugs&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500/ uL, platelet ≥ 100,000/ uL, haemoglobin&#xD;
                  (Hb) ≥ 9.0 g/dl,&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 mg/dL (If serum creatinine is greater than 1.5 mg/dL,&#xD;
                  creatinine clearance [Ccr] should be 60 mL/min or greater. Ccr is calculated by&#xD;
                  Cockcroft-Gault formula or 24hr urine collection)&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST/ALT levels ≤ 3.0 x ULN&#xD;
                  (AST/ALT levels ≤ 5.0 x ULN for patients with liver involvement of their cancer)&#xD;
&#xD;
          8. In patients who received adjuvant or neoadjuvant chemotherapy, completion of systemic&#xD;
             chemotherapy 6 months before the study enrollment, and no previous administration of&#xD;
             platinum derivatives&#xD;
&#xD;
          9. Estimated life expectancy of more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other histologic types than adenocarcinoma&#xD;
&#xD;
          2. Recurrence within 24 weeks following completion of adjuvant chemotherapy&#xD;
&#xD;
          3. R1 gastrectomy (i.e., microscopic residual disease)&#xD;
&#xD;
          4. History of another malignancy within the last five years from the day of written&#xD;
             informed consent except cured basal cell carcinoma of skin and cured carcinoma in situ&#xD;
             of uterine cervix&#xD;
&#xD;
          5. Radiotherapy within 4 weeks after randomization&#xD;
&#xD;
          6. History of significant neurologic or psychiatric disorders, and presence or history of&#xD;
             CNS metastasis&#xD;
&#xD;
          7. Major surgery within 4 weeks before study entry, or insufficient recovery from major&#xD;
             surgery (except the patients who received only open and closure or biopsy)&#xD;
&#xD;
          8. Other serious illness or medical conditions as follows;&#xD;
&#xD;
               -  Any following conditions occurred within 6 months before study entry: myocardial&#xD;
                  infarction, severe/unstable angina, bypass surgery for coronary artery/peripheral&#xD;
                  artery, congestive heart failure (NYHA class III or IV), cerebral infarction or&#xD;
                  transient ischemic attack&#xD;
&#xD;
               -  Conduction abnormality such as 2nd degree or greater AV block or severe&#xD;
                  arrhythmia that requires medical treatments (right bundle branch block (RBBB) is&#xD;
                  eligible, but left bundle branch block (LBBB) is not.)&#xD;
&#xD;
               -  Uncontrolled hypertension&#xD;
&#xD;
               -  Liver cirrhosis (Child Pugh Class B or greater)&#xD;
&#xD;
               -  Interstitial pneumonia, pulmonary fibrosis&#xD;
&#xD;
               -  Active viral hepatitis B&#xD;
&#xD;
               -  Uncontrolled diabetes mellitus&#xD;
&#xD;
               -  Uncontrolled ascites or pleural effusion&#xD;
&#xD;
               -  Uncontrolled active infection or sepsis&#xD;
&#xD;
          9. Administration of medications which may have potentially pharmacokinetic interaction&#xD;
             with S-1, cisplatin, and oxaliplatin&#xD;
&#xD;
               -  Flucytosine, a fluorinated pyrimidine antifungal agent&#xD;
&#xD;
               -  Anti-viral agents, such as sorivudine, and brivudine, or chemical similar drugs&#xD;
&#xD;
               -  Warfarin (except, low dose warfarin for the purpose of prophylaxis),&#xD;
                  phenprocoumon&#xD;
&#xD;
               -  Phenytoin&#xD;
&#xD;
               -  Allopurinol&#xD;
&#xD;
         10. Participation to other clinical trials or administration of other investigational&#xD;
             drugs within 30 days before the randomisation&#xD;
&#xD;
         11. Pregnant or lactating women&#xD;
&#xD;
         12. Women or men of child bearing potential not employing adequate contraception during&#xD;
             study treatments or until the 3 months after the end of study treatments&#xD;
&#xD;
         13. Ineligible for the study at the discretion of investigators&#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>Min-Hee Ryu, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Young-Iee Park, MD., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Seoul, Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ik-Joo Chung, MD., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Cheongju-si</city>
        <state>Chungcheongbuk-do</state>
        <zip>361-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Bundang-gu, Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Ilsan</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun-eup, Hwasun-gun</city>
        <state>Jeollanam-do</state>
        <zip>519-763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongnam Institute of Radiological and Medical Sciences</name>
      <address>
        <city>Busan</city>
        <zip>619-953</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeungnam University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>705-717</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangneung Asan Hospital</name>
      <address>
        <city>Gangneung-si</city>
        <zip>210-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's hospital of the Catholic University of Korea</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
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  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>November 26, 2015</last_update_submitted>
  <last_update_submitted_qc>November 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Min-Hee Ryu</investigator_full_name>
    <investigator_title>Asan Medical Center</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>S-1</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>Oxaliplatin</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>
  </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/NCT01671449
org study id: AMC-ONCGI-1202
nct id: NCT01671449
lead sponsor: 
has dmc: No
A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly)
      versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric
      cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
description: The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.
measure: Overall survival
time frame: From date of randomization to death from any cause, assessed up to 3 years
description: Overall survival is defined as the time from randomization to death due to any cause.
measure: Response rate
time frame: Every 6 weeks
description: Response assessment will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 every 2 cycles (6 weeks) of treatment.
measure: Quality of life
time frame: Every 6 weeks
description: Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.
measure: Number of Adverse Events
time frame: Every 3 weeks
description: Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.
arm group label: S-1 plus Cisplatin
arm group type: Active Comparator
description: S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.
Cisplatin: 60 mg/ m2/day, i.v., day 1
Every 3 weeks
arm group label: S-1 plus Oxaliplatin
arm group type: Experimental
description: S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.
Oxaliplatin: 130 mg/ m2/day, i.v., day 1
Every 3 weeks
intervention type: Drug
intervention name: S-1
description: S-1 : 40 mg/m2, twice daily, Day 1-14
arm group label: S-1 plus Cisplatin
arm group label: S-1 plus Oxaliplatin
other name: TS-1
intervention type: Drug
intervention name: Cisplatin
description: 60 mg/m2/day Day 1
arm group label: S-1 plus Cisplatin
intervention type: Drug
intervention name: Oxaliplatin
description: 130 mg/m2/day Day 1
arm group label: S-1 plus Oxaliplatin
other name: Pleoxin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Min-Hee Ryu, M.D., Ph.D
role: Principal Investigator
affiliation: Asan Medical Center
last name: Young-Iee Park, MD., Ph.D.
role: Principal Investigator
affiliation: National Cancer Center, Seoul, Korea
last name: Ik-Joo Chung, MD., Ph.D.
role: Principal Investigator
affiliation: Chonnam National University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
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PMID: 18665164
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Min-Hee Ryu
investigator title: Asan Medical Center
mesh term: Stomach Neoplasms
mesh term: Oxaliplatin