<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/NCT03769935</url>
  </required_header>
  <id_info>
    <org_study_id>QingdaoCH2018-12-02</org_study_id>
    <nct_id>NCT03769935</nct_id>
  </id_info>
  <brief_title>Maintenance Therapy for Small-cell Lung Cancer</brief_title>
  <official_title>Preliminary Study of Maintenance Therapy for Patients With Extensive Stage of Small-cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qingdao Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qingdao Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves patients treated with cisplatin and etoposide (induction therapy),&#xD;
      followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this&#xD;
      study is to determine if this type of treatment will delay the growth of the tumor and if so,&#xD;
      for how long. The primary endpoint is progression free survival and second endpoints are&#xD;
      toxicities, overall survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of&#xD;
      malignancy, short doubling time, early and widespread metastasis, is sensitive to&#xD;
      chemotherapy and radiotherapy, and has a high initial response rate, but is prone to&#xD;
      secondary drug resistance and relapse. The treatment is mainly based on systemic&#xD;
      chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy&#xD;
      could prolong progression free survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</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>The progression-free survival in this population of patients</measure>
    <time_frame>2.5 years</time_frame>
    <description>The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing an Adverse Event (AE)</measure>
    <time_frame>2.5 years</time_frame>
    <description>Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The overall survival in this population of patients.</measure>
    <time_frame>2.5 years</time_frame>
    <description>The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Progression Free Survival</condition>
  <arm_group>
    <arm_group_label>experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.&#xD;
S1 25 mg/m2 oral, everyday until progression disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cis Platinum, etoposide, S1</intervention_name>
    <description>cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.&#xD;
S1 25 mg/m2 oral, everyday until progression disease</description>
    <arm_group_label>active comparator</arm_group_label>
    <arm_group_label>experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Histopathologically confirmed patients with extensive small cell lung cancer; 2.&#xD;
             Karnofsky performance status ≥60; 3. At least one lesion that can measured by CT; 4.&#xD;
             Expected to survive for at least 3 months; 5. Peripheral blood and liver and kidney&#xD;
             function within the following allowable range (tested within 7 days before treatment);&#xD;
             6. White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L; Hemoglobin (HGB)&#xD;
             ≥80 g/L；Platelet (PLT) ≥100×109/L; 7. Liver transaminases（AST/ALT）&lt;3.0 times the&#xD;
             normal range limit; Total bilirubin（TBIL）&lt;1.5 times the normal range limit;&#xD;
             Creatinine（CREAT）&lt;1.5 times the normal range limit; 8. Patients of childbearing age&#xD;
             (including female and male patients' partner) must take effective contraception&#xD;
             methods; Signed informed consent 9. Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main&#xD;
             vesicular less than 5mm 3. Other pathological types of tumor except for small cell&#xD;
             lung cancer; 4. Patients with a history of severe allergies or allergies; 5. Pregnancy&#xD;
             or breastfeeding women; 6. Patients who have previously participated in other clinical&#xD;
             trials and have not yet terminated the trial; 7. Patients who have acute infection&#xD;
             that difficult to control; 8. Subjects with difficulties in swallowing or known drug&#xD;
             malabsorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Qingdao Central Hospital, Qingdao Cancer Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</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>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Cisplatin</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/NCT03769935
org study id: QingdaoCH2018-12-02
nct id: NCT03769935
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study involves patients treated with cisplatin and etoposide (induction therapy),
      followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this
      study is to determine if this type of treatment will delay the growth of the tumor and if so,
      for how long. The primary endpoint is progression free survival and second endpoints are
      toxicities, overall survival.
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of
      malignancy, short doubling time, early and widespread metastasis, is sensitive to
      chemotherapy and radiotherapy, and has a high initial response rate, but is prone to
      secondary drug resistance and relapse. The treatment is mainly based on systemic
      chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy
      could prolong progression free survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The progression-free survival in this population of patients
time frame: 2.5 years
description: The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
measure: Percentage of Participants Experiencing an Adverse Event (AE)
time frame: 2.5 years
description: Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
measure: The overall survival in this population of patients.
time frame: 2.5 years
description: The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1
arm group label: experimental arm
arm group type: Experimental
description: cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
arm group label: active comparator
arm group type: Active Comparator
description: cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
intervention type: Drug
intervention name: cis Platinum, etoposide, S1
description: cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
S1 25 mg/m2 oral, everyday until progression disease
arm group label: active comparator
arm group label: experimental arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Small Cell Lung Carcinoma
mesh term: Etoposide
mesh term: Cisplatin