<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/NCT03025958</url>
  </required_header>
  <id_info>
    <org_study_id>ZJCH-2016-HN04</org_study_id>
    <nct_id>NCT03025958</nct_id>
  </id_info>
  <brief_title>Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced&#xD;
      Nasopharyngeal Carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial&#xD;
      dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly&#xD;
      nimotuzumab (200 mg/week).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Toxicity was graded according to the National Cancer Institute-Common Toxicity Criteria for Adverse Events version 3.0.</measure>
    <time_frame>an average of 3 months</time_frame>
    <description>Safety</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Nimotuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimotuzumab</intervention_name>
    <arm_group_label>Nimotuzumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <arm_group_label>Nimotuzumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously untreated and histologically confirmed locoregionally advanced&#xD;
             nasopharyngeal carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of another invasive cancer, prior RT to the head and neck area, prior&#xD;
             cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical&#xD;
             conditions, supposed to live less than 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xiaozhong Chen</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaozhong Chen, MD</last_name>
      <phone>+86-571-88128202</phone>
      <email>cxzfyun@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</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>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nimotuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025958
org study id: ZJCH-2016-HN04
nct id: NCT03025958
lead sponsor: 
has dmc: Yes
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced
      Nasopharyngeal Carcinoma
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial
      dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly
      nimotuzumab (200 mg/week).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicity was graded according to the National Cancer Institute-Common Toxicity Criteria for Adverse Events version 3.0.
time frame: an average of 3 months
description: Safety
arm group label: Nimotuzumab
arm group type: Experimental
description: Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).
intervention type: Drug
intervention name: Nimotuzumab
arm group label: Nimotuzumab
intervention type: Radiation
intervention name: Radiation
arm group label: Nimotuzumab
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Nimotuzumab
sharing ipd: No