<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/NCT03830385</url>
  </required_header>
  <id_info>
    <org_study_id>B2018-138</org_study_id>
    <nct_id>NCT03830385</nct_id>
  </id_info>
  <brief_title>Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck</brief_title>
  <official_title>Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and&#xD;
      efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the&#xD;
      treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Anticipated">February 15, 2026</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2021</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>overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>overall survival</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Squamous Cell Carcinoma Of The Head And Neck</condition>
  <arm_group>
    <arm_group_label>Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin</intervention_name>
    <description>All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy</description>
    <arm_group_label>Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biopsy proved squamous cell carcinoma of the head and neck;&#xD;
&#xD;
          -  stage IVc according to Union for International Cancer Control (UICC) edition VIII, or&#xD;
             recurrent disease after chemotherapy and/or radiotherapy;&#xD;
&#xD;
          -  18 years or older; without other malignancy;&#xD;
&#xD;
          -  proper functioning of the major organs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ;&#xD;
&#xD;
          -  female within gestation period or lactation;&#xD;
&#xD;
          -  patients received drug of other clinical trial within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qingqing Cai, PhD</last_name>
    <phone>0086-20-87342823</phone>
    <email>caiqq@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhihua Li, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 13, 2019</last_update_submitted>
  <last_update_submitted_qc>July 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Qingqing Cai</investigator_full_name>
    <investigator_title>Chief physician</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>Carboplatin</mesh_term>
    <mesh_term>Bleomycin</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/NCT03830385
org study id: B2018-138
nct id: NCT03830385
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and
      efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the
      treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall survival
time frame: 5 years
description: overall survival
arm group label: Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or
arm group type: Experimental
intervention type: Drug
intervention name: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
description: All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy
arm group label: Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Qingqing Cai, PhD
phone: 0086-20-87342823
email: caiqq@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Qingqing Cai
investigator title: Chief physician
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Carboplatin
mesh term: Bleomycin