<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/NCT02972216</url>
  </required_header>
  <id_info>
    <org_study_id>YSP RFH3001-01</org_study_id>
    <nct_id>NCT02972216</nct_id>
  </id_info>
  <brief_title>Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy</brief_title>
  <official_title>A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung Shin Pharm. Ind. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yung Shin Pharm. Ind. Co., Ltd.</source>
  <brief_summary>
    <textblock>
      A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of&#xD;
      Docetaxel-Based Chemotherapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events as a measure on safety</measure>
    <time_frame>Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <condition>Squamous Cell Carcinoma of the Head and Neck</condition>
  <arm_group>
    <arm_group_label>Nolbaxol</arm_group_label>
    <description>For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 ~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Taxotere</arm_group_label>
    <description>For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 ~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nolbaxol</intervention_name>
    <arm_group_label>Nolbaxol</arm_group_label>
    <other_name>docetaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Taxotere</intervention_name>
    <arm_group_label>Taxotere</arm_group_label>
    <other_name>docetaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <arm_group_label>Nolbaxol</arm_group_label>
    <arm_group_label>Taxotere</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 40 evaluable patients with locally advanced or metastatic NSCLC, SCCHN or&#xD;
        esophageal cancer will be equally randomized to either Nolbaxol or Taxotere.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Histologically or cytologically confirmed unresectable locally advanced NSCLC with&#xD;
        progressed or recurred after no more than four previous docetaxel-free chemotherapy&#xD;
        regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous&#xD;
        docetaxel-free chemotherapy regimens&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are nursing or pregnant during the study period;&#xD;
&#xD;
          2. Patients with carcinoid tumors, small-cell carcinoma of the lung;&#xD;
&#xD;
          3. A history of another malignancy within the last five years (except for cured basal&#xD;
             cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);&#xD;
&#xD;
          4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active&#xD;
             infection, myocardial infarction in the preceding 6 months);&#xD;
&#xD;
          5. Neutrophil counts &lt; 1,500 cells/mm3;&#xD;
&#xD;
          6. A history of hypersensitivity to docetaxel or cisplatin;&#xD;
&#xD;
          7. Symptomatic heart disease including unstable angina, congestive heart failure or&#xD;
             uncontrolled arrhythmias;&#xD;
&#xD;
          8. Subjects have active hepatitis;&#xD;
&#xD;
          9. Subjects are known positive for Human Immunodeficiency Virus (HIV);&#xD;
&#xD;
         10. Any condition judged by investigator, participates the study will jeopardize patient's&#xD;
             wellbeing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</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>Squamous Cell Carcinoma of Head and Neck</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>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/NCT02972216
org study id: YSP RFH3001-01
nct id: NCT02972216
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of
      Docetaxel-Based Chemotherapy
observational model: Case-Control
time perspective: Retrospective
measure: Progression-Free Survival (PFS)
time frame: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
measure: Overall Response Rate (ORR)
time frame: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
measure: Adverse Events as a measure on safety
time frame: Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.
arm group label: Nolbaxol
description: For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 ~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.
arm group label: Taxotere
description: For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 ~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.
intervention type: Drug
intervention name: Nolbaxol
arm group label: Nolbaxol
other name: docetaxel
intervention type: Drug
intervention name: Taxotere
arm group label: Taxotere
other name: docetaxel
intervention type: Drug
intervention name: cisplatin
arm group label: Nolbaxol
arm group label: Taxotere
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel