<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/NCT01689194</url>
  </required_header>
  <id_info>
    <org_study_id>CRCST-L-0007</org_study_id>
    <secondary_id>H-1204-103-407</secondary_id>
    <nct_id>NCT01689194</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer</brief_title>
  <official_title>A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Research Center for Solid Tumor, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using&#xD;
      Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to&#xD;
      evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2013</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response rate</measure>
    <time_frame>every 2 cycles, 6wk later after chemotherapy</time_frame>
    <description>RECIST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Locoregional control rate</measure>
    <time_frame>every 3wk (every cycle)</time_frame>
    <description>NCI CTCAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>every 3wk (every cycle)</time_frame>
    <description>EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety</measure>
    <time_frame>every 3wk (every cycle)</time_frame>
    <description>NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Locally Advanced Head and Neck Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>genexolPM + cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>genexolPM + cisplatin</intervention_name>
    <arm_group_label>genexolPM + cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  locally advanced head and neck squamous cell carcinoma&#xD;
&#xD;
          -  oral cavity, oropharynx, hypopharynx, larynx&#xD;
&#xD;
          -  measurable lesion&#xD;
&#xD;
          -  unresectable&#xD;
&#xD;
          -  age 18 or more&#xD;
&#xD;
          -  ECOG 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  distant metastasis&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  prior chemotherapy or radiation therapy&#xD;
&#xD;
          -  2ndary malignancy&#xD;
&#xD;
          -  other unfit medical condition&#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>Se-Hoon Lee, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Se-Hoon Lee</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>genexol-PM</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/NCT01689194
org study id: CRCST-L-0007
secondary id: H-1204-103-407
nct id: NCT01689194
lead sponsor: 
collaborator: 
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using
      Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to
      evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response rate
time frame: every 2 cycles, 6wk later after chemotherapy
description: RECIST
measure: Locoregional control rate
time frame: every 3wk (every cycle)
description: NCI CTCAE
measure: Quality of life
time frame: every 3wk (every cycle)
description: EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
measure: safety
time frame: every 3wk (every cycle)
description: NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity
arm group label: genexolPM + cisplatin
arm group type: Experimental
intervention type: Drug
intervention name: genexolPM + cisplatin
arm group label: genexolPM + cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Se-Hoon Lee, MD PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Se-Hoon Lee
investigator title: professor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: genexol-PM