<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/NCT02223611</url>
  </required_header>
  <id_info>
    <org_study_id>HBMF9990</org_study_id>
    <nct_id>NCT02223611</nct_id>
  </id_info>
  <brief_title>Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection</brief_title>
  <acronym>S1VSNP</acronym>
  <official_title>Phase ⅡTrial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage Ⅱ-ⅢA Non-small Cell Lung Cancer (NSCLC) After Complete Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Medical University Fourth Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in&#xD;
      stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate&#xD;
      the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer&#xD;
      patients after the complete resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung&#xD;
      cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC)&#xD;
      accounts for more than 85% of all lung cancer cases.&#xD;
&#xD;
      For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy&#xD;
      is the mainstay of first line treatment. Various treatment regimens have been developed to&#xD;
      improve survival.&#xD;
&#xD;
      S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of&#xD;
      5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an&#xD;
      active single agent against NSCLC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Disease free survival rate</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>4 years</time_frame>
    <description>The period from the date of enrollment to the date on which the recurrence was first confirmed. For patients who died before disease progression from any cause, death was attributed to recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>4 years</time_frame>
    <description>The period from the date of enrollment to the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.</time_frame>
    <description>The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.</time_frame>
    <description>QOL was assessed with the lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale(LCSS).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Molecular marker measurement for NSCLC</measure>
    <time_frame>Some molecular markers in the serum will be tested at 6-month intervals after surgery until recurrence</time_frame>
    <description>The measured molecular markers include carcinoembryonic antigen (CEA), tissue polypeptide specific antigen (TPS), neuron-specific enolase (NSE), carbohydrate antigen 199 (CA199), cytokeratin fragment 19 ( CYFRA 21-1), and squamous cell carcinoma antigen (SCC Ag)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Non-small Cell Lung Cancer Stage Ⅱ</condition>
  <condition>Non-small Cell Lung Cancer Stage ⅢA</condition>
  <arm_group>
    <arm_group_label>S1 capsule plus Cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S1: 40mg, bid, when body surface area (BSA)&lt;1.25 m2, 50mg; bid when 1.25 m2≤BSA&lt;1.5 m2; 60mg, bid when 1.5 m2≤BSA 60mg from day 1 to 14. Cisplatin: 75 mg/m2 on day 1.&#xD;
3 weeks/4cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vinorelbine plus Cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1.&#xD;
3 weeks/4cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S1 capsule</intervention_name>
    <description>Within four weeks after the completely resection, S-1 was administered orally twice a day, after meals on days 1 to 14. The actual dose of S-1 was selected as follows: in a patient with body surface area (BSA)&lt;1.25 m2 40mg twice a day, 1.25 m2≤BSA&lt;1.5 m2 50mg twice a day, and 1.5 m2≤BSA 60mg twice a day. Cisplatin (75 mg/m2) was administered intravenously on day 1 The treatment regimen was repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.</description>
    <arm_group_label>S1 capsule plus Cisplatin</arm_group_label>
    <other_name>S1: Gimeracil and oteracil porassium capsules</other_name>
    <other_name>Cisplatin: Cisplatin for injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>Vinorelbine (25 mg/m2) is administered intravenously on day 1, and day 8. Cisplatin (75 mg/m2) is administered intravenously on day 1. The treatment regimen is repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.</description>
    <arm_group_label>Vinorelbine plus Cisplatin</arm_group_label>
    <other_name>Vinorelbine: Navelbine,vinorelbine bitartrate injection</other_name>
    <other_name>Cisplatin: Cisplatin for injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)&#xD;
&#xD;
          -  Must be able to receive the therapy of the study within four weeks after the&#xD;
             completely resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic anticancer treatment&#xD;
&#xD;
          -  local radiotherapy&#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>Jun-Feng Liu, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Thoracic Surgery Fourth Hospital, Hebei Medical University, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Feng Liu, Professor</last_name>
    <phone>+86-311-86095353</phone>
    <email>liujf@heinfo.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yun Jiang Liu, Professor</last_name>
    <phone>+86-13703297890</phone>
    <email>lyj818326@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jun Feng Liu</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xin-Bo Liu, MD</last_name>
      <phone>+86-311-86095353</phone>
      <email>lxbbbsj@163.com</email>
    </contact>
    <investigator>
      <last_name>Jun Feng Liu, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Vinorelbine</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/NCT02223611
org study id: HBMF9990
nct id: NCT02223611
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in
      stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate
      the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer
      patients after the complete resection.
Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung
      cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC)
      accounts for more than 85% of all lung cancer cases.

      For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy
      is the mainstay of first line treatment. Various treatment regimens have been developed to
      improve survival.

      S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of
      5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an
      active single agent against NSCLC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival rate
time frame: 2 years
measure: Disease free survival
time frame: 4 years
description: The period from the date of enrollment to the date on which the recurrence was first confirmed. For patients who died before disease progression from any cause, death was attributed to recurrence.
measure: Overall survival
time frame: 4 years
description: The period from the date of enrollment to the date of death from any cause.
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
description: The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 4.0.
measure: Quality of life (QOL)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
description: QOL was assessed with the lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale(LCSS).
measure: Molecular marker measurement for NSCLC
time frame: Some molecular markers in the serum will be tested at 6-month intervals after surgery until recurrence
description: The measured molecular markers include carcinoembryonic antigen (CEA), tissue polypeptide specific antigen (TPS), neuron-specific enolase (NSE), carbohydrate antigen 199 (CA199), cytokeratin fragment 19 ( CYFRA 21-1), and squamous cell carcinoma antigen (SCC Ag)
arm group label: S1 capsule plus Cisplatin
arm group type: Experimental
description: S1: 40mg, bid, when body surface area (BSA)<1.25 m2, 50mg; bid when 1.25 m2≤BSA<1.5 m2; 60mg, bid when 1.5 m2≤BSA 60mg from day 1 to 14. Cisplatin: 75 mg/m2 on day 1.
3 weeks/4cycles
arm group label: Vinorelbine plus Cisplatin
arm group type: Active Comparator
description: Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1.
3 weeks/4cycles
intervention type: Drug
intervention name: S1 capsule
description: Within four weeks after the completely resection, S-1 was administered orally twice a day, after meals on days 1 to 14. The actual dose of S-1 was selected as follows: in a patient with body surface area (BSA)<1.25 m2 40mg twice a day, 1.25 m2≤BSA<1.5 m2 50mg twice a day, and 1.5 m2≤BSA 60mg twice a day. Cisplatin (75 mg/m2) was administered intravenously on day 1 The treatment regimen was repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.
arm group label: S1 capsule plus Cisplatin
other name: S1: Gimeracil and oteracil porassium capsules
other name: Cisplatin: Cisplatin for injection
intervention type: Drug
intervention name: Vinorelbine
description: Vinorelbine (25 mg/m2) is administered intravenously on day 1, and day 8. Cisplatin (75 mg/m2) is administered intravenously on day 1. The treatment regimen is repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.
arm group label: Vinorelbine plus Cisplatin
other name: Vinorelbine: Navelbine,vinorelbine bitartrate injection
other name: Cisplatin: Cisplatin for injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jun-Feng Liu, Professor
role: Principal Investigator
affiliation: Department of Thoracic Surgery Fourth Hospital, Hebei Medical University, China
last name: Jun Feng Liu, Professor
phone: +86-311-86095353
email: liujf@heinfo.net
last name: Yun Jiang Liu, Professor
phone: +86-13703297890
email: lyj818326@126.com
facility: 
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Cisplatin
mesh term: Vinorelbine