<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/NCT01679340</url>
  </required_header>
  <id_info>
    <org_study_id>SOXSP</org_study_id>
    <nct_id>NCT01679340</nct_id>
  </id_info>
  <brief_title>A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery</brief_title>
  <official_title>Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taiho Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and&#xD;
      III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less&#xD;
      toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">March 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>replase free survival</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>S-1+oxaliplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S-1+cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1</intervention_name>
    <description>Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles</description>
    <arm_group_label>S-1+cisplatin</arm_group_label>
    <arm_group_label>S-1+oxaliplatin</arm_group_label>
    <other_name>TS-1</other_name>
    <other_name>Aisiwan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxaliplatin</intervention_name>
    <description>Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles</description>
    <arm_group_label>S-1+oxaliplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle</description>
    <arm_group_label>S-1+cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric&#xD;
             junction ( AJCC 7th)&#xD;
&#xD;
          -  without previous treatment, including radiotherapy, chemotherapy and immunotherapy&#xD;
&#xD;
          -  Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L&#xD;
&#xD;
          -  creatinine≤1 UNL&#xD;
&#xD;
          -  total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL&#xD;
&#xD;
          -  ECOG score 0 - 2&#xD;
&#xD;
          -  take chemotherapy for 8 weeks after surgery&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
          -  can be followed up, good compliance&#xD;
&#xD;
          -  can take medicine orally&#xD;
&#xD;
          -  having signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  combined disease lead to Life Expectancy less than 3 years&#xD;
&#xD;
          -  any evidence to show metastasis,including cancer cells in peritoneal fluid&#xD;
&#xD;
          -  inability to take oral medication for difficult to swallow, intestinal&#xD;
             obstruction，active intestinal blooding or perforation&#xD;
&#xD;
          -  previous treatment,including cytotoxic chemotherapy, radio chemotherapy or&#xD;
             immunotherapy ( except corticosteroid hormone）&#xD;
&#xD;
          -  operation within 4 weeks, or not recovered from last major operation&#xD;
&#xD;
          -  allergy with fluorouracil&#xD;
&#xD;
          -  allergy with Platinum or any composition in research drugs&#xD;
&#xD;
          -  uncontrollable seizure disorder，central nervous system disease or mental disorders,&#xD;
             and has clinical significance by judgement of researchers, or can influnce&#xD;
             understanding of informed consent or compliance to take orally drugs&#xD;
&#xD;
          -  in the past 12 months, has clinical significant heart disease(active),such as&#xD;
             symptomatic coronary heart disease, &gt; =Stage II congestive cardiac failure;congestive&#xD;
             heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix&#xD;
             10th),or myocardical infarction.&#xD;
&#xD;
          -  pregnancy， lactation， women in child-bearing period and her spouses reject to take&#xD;
             effictive method to conraception&#xD;
&#xD;
          -  other previous malignancy within 5 years, except healed skin basal cell carcinoma and&#xD;
             carcinoma in cervix&#xD;
&#xD;
          -  peripheral neuropathy&gt; grade 1 of CTCAEv3, except the neural abnormality patients who&#xD;
             only lose deep tendon reflex（DTRs）.&#xD;
&#xD;
          -  serious complicated infection or other complicated diseases and hard to controll.&#xD;
&#xD;
          -  As one of belowing:&#xD;
&#xD;
          -  ANC &lt; 2×109/L&#xD;
&#xD;
          -  Platelet&lt;100×109/L&#xD;
&#xD;
          -  total bilirubin&gt;1.5 UNL&#xD;
&#xD;
          -  ALAT、ASAT &gt; 2.5 x ULN&#xD;
&#xD;
          -  ALP&gt; 2.5 x ULN&#xD;
&#xD;
          -  Any investigational agent within the past 28 days. That is the patient had jioned&#xD;
             another trial.&#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_contact>
    <last_name>Shen Lin, professor</last_name>
    <phone>010-88196561</phone>
    <email>xiaotong10241@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shen Lin, Professor</last_name>
      <phone>010-88196561</phone>
      <email>xiaotong10241@sina.com</email>
    </contact>
    <investigator>
      <last_name>Shen Lin, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>June 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 17, 2015</last_update_submitted>
  <last_update_submitted_qc>May 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Shen Lin</investigator_full_name>
    <investigator_title>Director of GI oncology</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>D2 surgery</keyword>
  <keyword>S-1</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>cisplatin</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/NCT01679340
org study id: SOXSP
nct id: NCT01679340
lead sponsor: 
collaborator: 
has dmc: Yes
To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and
      III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less
      toxicity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: replase free survival
time frame: 3 months
measure: overall survival
time frame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 3 months
arm group label: S-1+oxaliplatin
arm group type: Experimental
description: S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
arm group label: S-1+cisplatin
arm group type: Active Comparator
description: S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
intervention type: Drug
intervention name: S-1
description: Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
arm group label: S-1+cisplatin
arm group label: S-1+oxaliplatin
other name: TS-1
other name: Aisiwan
intervention type: Drug
intervention name: oxaliplatin
description: Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles
arm group label: S-1+oxaliplatin
intervention type: Drug
intervention name: cisplatin
description: Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle
arm group label: S-1+cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shen Lin, professor
phone: 010-88196561
email: xiaotong10241@sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Shen Lin
investigator title: Director of GI oncology
mesh term: Stomach Neoplasms
mesh term: Oxaliplatin