<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/NCT01712919</url>
  </required_header>
  <id_info>
    <org_study_id>LA-chemoR-c225</org_study_id>
    <secondary_id>JSCC-SACT-01</secondary_id>
    <nct_id>NCT01712919</nct_id>
  </id_info>
  <brief_title>Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)</brief_title>
  <official_title>IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Cancer Institute &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Cancer Institute &amp; Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation&#xD;
      against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and&#xD;
      efficacy of this new regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 1/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>Number of Participants with Adverse Events as a Measure of Safety</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and tolerability</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress free survival</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>local-relapse free survival</measure>
    <time_frame>24 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>cetuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-modulated radiotherapy</intervention_name>
    <description>Patients will be given intensity-modulated radiotherapy(IMRT)</description>
    <arm_group_label>cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Concurrent chemotherapy with paclitaxel and nedaplatin</intervention_name>
    <description>Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin</description>
    <arm_group_label>cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <description>Patients will be given cetuximab weekly during radiation therapy</description>
    <arm_group_label>cetuximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed untreated NPC patients&#xD;
&#xD;
          -  locoregionally advanced (T3-4 or N2-3 M0)&#xD;
&#xD;
          -  18-65 years&#xD;
&#xD;
          -  with MRI examinations&#xD;
&#xD;
          -  ECOG ≤ 2&#xD;
&#xD;
          -  With written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Without a second cancer&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  With other severe diseases (blood,liver ,kidney or heart diseases)&#xD;
&#xD;
          -  Could not be staged properly&#xD;
&#xD;
          -  Without written consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xia He, M.D. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jiangsu Cancer Institute &amp; Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>March 21, 2014</last_update_submitted>
  <last_update_submitted_qc>March 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jiangsu Cancer Institute &amp; Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Xia He</investigator_full_name>
    <investigator_title>Director of the department of radiation oncology</investigator_title>
  </responsible_party>
  <keyword>Locoregionally advanced nasopharyngeal carcinoma</keyword>
  <keyword>cetuximab</keyword>
  <keyword>chemoradiation</keyword>
  <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>Paclitaxel</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Nedaplatin</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/NCT01712919
org study id: LA-chemoR-c225
secondary id: JSCC-SACT-01
nct id: NCT01712919
lead sponsor: 
has dmc: Yes
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation
      against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and
      efficacy of this new regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Adverse Events as a Measure of Safety
time frame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
time frame: 6 months
measure: Progress free survival
time frame: 24 months
measure: local-relapse free survival
time frame: 24 months
arm group label: cetuximab
arm group type: Experimental
description: Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.
intervention type: Radiation
intervention name: Intensity-modulated radiotherapy
description: Patients will be given intensity-modulated radiotherapy(IMRT)
arm group label: cetuximab
intervention type: Drug
intervention name: Concurrent chemotherapy with paclitaxel and nedaplatin
description: Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin
arm group label: cetuximab
intervention type: Biological
intervention name: Cetuximab
description: Patients will be given cetuximab weekly during radiation therapy
arm group label: cetuximab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xia He, M.D. Ph.D.
role: Principal Investigator
affiliation: Jiangsu Cancer Institute & Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jiangsu Cancer Institute & Hospital
investigator full name: Dr. Xia He
investigator title: Director of the department of radiation oncology
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Paclitaxel
mesh term: Cetuximab
mesh term: Nedaplatin