<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/NCT01718626</url>
  </required_header>
  <id_info>
    <org_study_id>HBTH101</org_study_id>
    <nct_id>NCT01718626</nct_id>
  </id_info>
  <brief_title>Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Tumor Hospital</source>
  <brief_summary>
    <textblock>
      Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to&#xD;
      concomitant S1+Docetaxel in the safety and clinical efficiency.&#xD;
&#xD;
      Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance&#xD;
      treatment for advanced gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Progression-free survival(PFS)</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate(ORR)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate(DCR)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>S1+Docetaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>S1+Docetaxel followed by S1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S1+Docetaxel</intervention_name>
    <description>Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression</description>
    <arm_group_label>S1+Docetaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S1+Docetaxel followed by S1</intervention_name>
    <description>Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression</description>
    <arm_group_label>S1+Docetaxel followed by S1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1&#xD;
&#xD;
          -  Histologically or cytologically confirmed gastric cancer&#xD;
&#xD;
          -  Advanced or recurrent, metastatic disease&#xD;
&#xD;
          -  At least have one measurable disease(according to RECIST, Response Evaluation Criteria&#xD;
             in Solid Tumors )&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
          -  Target target lesion has not received radiotherapy or non target lesion radiation at&#xD;
             least 4 weeks&#xD;
&#xD;
          -  Haematopoietic and Hepatic status:&#xD;
&#xD;
        Absolute neutrophil count &gt;1.5x109/L,Platelet count &gt; 100 x 109/L,Hemoglobin at least 9&#xD;
        g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver&#xD;
        metastasis), ≤5 times ULN(with liver metastasis)&#xD;
&#xD;
          -  Cardiovascular: Baseline LVEF 50% measured by echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic brain metastasis&#xD;
&#xD;
          -  Active or uncontrolled infection&#xD;
&#xD;
          -  Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities&#xD;
             greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain&#xD;
             metastasis&#xD;
&#xD;
          -  Known history of uncontrolled or symptomatic angina, clinically significant&#xD;
             arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable&#xD;
             diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen&#xD;
&#xD;
          -  History of other malignancy&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei Tumor Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medical Oncology</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Docetaxel</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/NCT01718626
org study id: HBTH101
nct id: NCT01718626
lead sponsor: 
Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to
      concomitant S1+Docetaxel in the safety and clinical efficiency.

      Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance
      treatment for advanced gastric cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival(PFS)
time frame: 1 years
measure: Objective response rate(ORR)
time frame: 1 year
measure: Disease control rate(DCR)
time frame: 1 year
measure: Overall survival(OS)
time frame: 3 years
arm group label: S1+Docetaxel
arm group type: Active Comparator
arm group label: S1+Docetaxel followed by S1
arm group type: Experimental
intervention type: Drug
intervention name: S1+Docetaxel
description: Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression
arm group label: S1+Docetaxel
intervention type: Drug
intervention name: S1+Docetaxel followed by S1
description: Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression
arm group label: S1+Docetaxel followed by S1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wei Liu
role: Principal Investigator
affiliation: Hebei Tumor Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Docetaxel