<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/NCT01694576</url>
  </required_header>
  <id_info>
    <org_study_id>NPC-N23-RCT</org_study_id>
    <secondary_id>JSCC-RCT01</secondary_id>
    <nct_id>NCT01694576</nct_id>
  </id_info>
  <brief_title>NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation</brief_title>
  <official_title>Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ 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>
      By this clinical trial, the investigators are trying to give an answer to such a question.&#xD;
      Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and&#xD;
      platinum after concurrent chemoradiation?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding&#xD;
      adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally&#xD;
      advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is&#xD;
      adjuvant chemotherapy necessary?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow patient enrollment&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 2</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>treatment toxicity based on a CTCAE3.0 grading system</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>distant metastasis free survival</measure>
    <time_frame>24 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Adjuvant chemotherapy with paclitaxel and nedaplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvant chemotherapy with paclitaxel and nedaplatin</intervention_name>
    <description>Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation</description>
    <arm_group_label>Adjuvant chemotherapy with paclitaxel and nedaplatin</arm_group_label>
    <other_name>Adjuvant chemotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. pathologically confirmed untreated NPC patients staged N2-3M0&#xD;
&#xD;
          2. age: 18y - 65y&#xD;
&#xD;
          3. with MRI examinations&#xD;
&#xD;
          4. ECOG≤2&#xD;
&#xD;
          5. with written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. without a second cancer&#xD;
&#xD;
          2. pregnancy&#xD;
&#xD;
          3. with other severe diseases(blood,liver ,kidney or heart diseases)&#xD;
&#xD;
          4. could not staged properly&#xD;
&#xD;
          5. 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. and PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Radiotherapy,Jiangsu Cancer 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>June 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>June 12, 2015</last_update_submitted>
  <last_update_submitted_qc>June 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 15, 2015</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 radiotherapy</investigator_title>
  </responsible_party>
  <keyword>Nasopharyngeal carcinoma staged N2-3M0</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>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/NCT01694576
org study id: NPC-N23-RCT
secondary id: JSCC-RCT01
nct id: NCT01694576
lead sponsor: 
has dmc: Yes
By this clinical trial, the investigators are trying to give an answer to such a question.
      Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and
      platinum after concurrent chemoradiation?
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding
      adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally
      advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is
      adjuvant chemotherapy necessary?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: treatment toxicity based on a CTCAE3.0 grading system
time frame: 6 months
measure: progress free survival
time frame: 24 months
measure: distant metastasis free survival
time frame: 24 months
arm group label: Adjuvant chemotherapy with paclitaxel and nedaplatin
arm group type: Experimental
description: Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
arm group label: Observation
arm group type: No Intervention
description: Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation
intervention type: Drug
intervention name: Adjuvant chemotherapy with paclitaxel and nedaplatin
description: Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
arm group label: Adjuvant chemotherapy with paclitaxel and nedaplatin
other name: Adjuvant chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xia He, M.D. and PhD
role: Principal Investigator
affiliation: Department of Radiotherapy,Jiangsu Cancer 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 radiotherapy
mesh term: Nasopharyngeal Carcinoma
mesh term: Paclitaxel
mesh term: Nedaplatin