<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/NCT03837808</url>
  </required_header>
  <id_info>
    <org_study_id>2018-FXY-206</org_study_id>
    <nct_id>NCT03837808</nct_id>
  </id_info>
  <brief_title>Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma</brief_title>
  <official_title>A Randomized Phase III Non-inferiority Study of Radiotherapy Plus Concurrent Nimotuzumab Versus Cisplatin in Stage II-III Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</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 is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined&#xD;
      with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III&#xD;
      nasopharyngeal carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scheme:&#xD;
&#xD;
      Eligible stage II and III NPC patients will first be stratified by institution, then&#xD;
      randomized to 2 arms at 1:1 ratio.&#xD;
&#xD;
      - Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT&#xD;
&#xD;
      - Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">February 11, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 11, 2024</primary_completion_date>
  <phase>Phase 3</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>Progress-free survival (PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional Relapse-Free Survival (LRRFS)</measure>
    <time_frame>2 years</time_frame>
    <description>The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival (DMFS)</measure>
    <time_frame>2 years</time_frame>
    <description>The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">384</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Nasopharyngeal Neoplasms</condition>
  <condition>Nasopharyngeal Diseases</condition>
  <condition>Head and Neck Neoplasm</condition>
  <arm_group>
    <arm_group_label>Nimotuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nimotuzumab 200mg/week in concurrent with IMRT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cisplatin 40mg/m2/week in concurrent with IMRT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimotuzumab</intervention_name>
    <description>nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT</description>
    <arm_group_label>Nimotuzumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT</description>
    <arm_group_label>Cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly histologically confirmed non-keratinizing nasopharyngeal&#xD;
             carcinoma, including WHO II or III&#xD;
&#xD;
          -  histologically confirmed positive EGFR expression&#xD;
&#xD;
          -  Stage II and III NPC patients（according to the 8th AJCC edition）&#xD;
&#xD;
          -  Male and no pregnant female&#xD;
&#xD;
          -  Age between 18-65&#xD;
&#xD;
          -  Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count&#xD;
             ≥100000/μL&#xD;
&#xD;
          -  Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase&#xD;
             (AST) &lt;2.0×upper limit of normal (ULN)&#xD;
&#xD;
          -  Adequate renal function: creatinine clearance ≥60 ml/min&#xD;
&#xD;
          -  Satisfactory performance status: Karnofsky scale (KPS) &gt; 70&#xD;
&#xD;
          -  Without radiotherapy or chemotherapy&#xD;
&#xD;
          -  Patients must give signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of relapse or distant metastasis&#xD;
&#xD;
          -  History of prior malignancy or previous treatment for NPC&#xD;
&#xD;
          -  Any severe intercurrent disease, which may bring unacceptable risk or affect the&#xD;
             compliance of the trial, for example, unstable cardiac disease requiring treatment,&#xD;
             renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose&#xD;
             &gt;1.5×ULN), and emotional disturbance.&#xD;
&#xD;
          -  Pregnancy or lactation&#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_official>
    <last_name>Ming-Yuan Chen, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Yuan Chen, MD,PhD</last_name>
    <phone>+86-20-87343361</phone>
    <email>chenmy@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui-Hua Xu, MD,PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Ming-Yuan Chen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>nimotuzumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nimotuzumab</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/NCT03837808
org study id: 2018-FXY-206
nct id: NCT03837808
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined
      with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III
      nasopharyngeal carcinoma.
Scheme:

      Eligible stage II and III NPC patients will first be stratified by institution, then
      randomized to 2 arms at 1:1 ratio.

      - Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT

      - Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress-free survival (PFS)
time frame: 2 years
description: Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
measure: Overall Survival (OS)
time frame: 2 years
description: The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
measure: Locoregional Relapse-Free Survival (LRRFS)
time frame: 2 years
description: The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
measure: Distant Metastasis-Free Survival (DMFS)
time frame: 2 years
description: The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
measure: Number of participants with adverse events
time frame: up to 2 years
arm group label: Nimotuzumab
arm group type: Experimental
description: nimotuzumab 200mg/week in concurrent with IMRT
arm group label: Cisplatin
arm group type: Active Comparator
description: cisplatin 40mg/m2/week in concurrent with IMRT
intervention type: Drug
intervention name: Nimotuzumab
description: nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
arm group label: Nimotuzumab
intervention type: Drug
intervention name: Cisplatin
description: cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
arm group label: Cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ming-Yuan Chen, MD,PhD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Ming-Yuan Chen, MD,PhD
phone: +86-20-87343361
email: chenmy@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Ming-Yuan Chen
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Nasopharyngeal Carcinoma
mesh term: Head and Neck Neoplasms
mesh term: Nasopharyngeal Neoplasms
mesh term: Nasopharyngeal Diseases
mesh term: Nimotuzumab