<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/NCT02187315</url>
  </required_header>
  <id_info>
    <org_study_id>20140501</org_study_id>
    <nct_id>NCT02187315</nct_id>
  </id_info>
  <brief_title>Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study</brief_title>
  <official_title>Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Feng Jing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guiyang Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent&#xD;
      combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with&#xD;
      induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with&#xD;
      intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of&#xD;
      locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two&#xD;
      groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative&#xD;
      effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety</measure>
    <time_frame>5 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with curative effect</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Melodie group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine-chemotherapy group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chrono-chemotherapy pump:Melodie</intervention_name>
    <arm_group_label>Melodie group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Routine intravenous drip</intervention_name>
    <arm_group_label>Routine-chemotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>induction chemotherapy</intervention_name>
    <arm_group_label>Melodie group</arm_group_label>
    <arm_group_label>Routine-chemotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin chrono-chemotherapy</intervention_name>
    <arm_group_label>Melodie group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>intensity-modulated radiation therapy</intervention_name>
    <arm_group_label>Melodie group</arm_group_label>
    <arm_group_label>Routine-chemotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin routine-chemotherapy</intervention_name>
    <arm_group_label>Routine-chemotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced&#xD;
             nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no&#xD;
             evidence of distant metastasis (M0). A measurable tumor lesions;&#xD;
&#xD;
          2. Karnofsky score≥70;&#xD;
&#xD;
          3. Age 18-70 years old, male or female;&#xD;
&#xD;
          4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood&#xD;
             cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total&#xD;
             bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper&#xD;
             limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of&#xD;
             normal) electrocardiogram does not affect the normal treatment;&#xD;
&#xD;
          5. To understand this study and sign informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A distant metastasis;&#xD;
&#xD;
          2. Patients with physical or mental illness, and researchers think that patients can't&#xD;
             fully or adequately understand the possible complications of this study;&#xD;
&#xD;
          3. Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;&#xD;
&#xD;
          4. Serious complications, such as uncontrollable hypertension, heart function failure,&#xD;
             diabetes, etc.; 5.Who had received radiation and chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Feng Jin, Professor</last_name>
    <phone>+86 13985124806</phone>
    <email>jinf8865@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Jin, Professor</last_name>
      <phone>+86 13985124806</phone>
      <email>jinf8865@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>May 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guiyang Medical University</investigator_affiliation>
    <investigator_full_name>Feng Jing</investigator_full_name>
    <investigator_title>Guiyang Medical College</investigator_title>
  </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>Cisplatin</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/NCT02187315
org study id: 20140501
nct id: NCT02187315
lead sponsor: 
has dmc: No
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent
      combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with
      induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with
      intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of
      locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two
      groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative
      effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Number of Participants with Adverse Events as a Measure of Safety
time frame: 5 year
measure: Number of Participants with curative effect
time frame: 1 year
arm group label: Melodie group
arm group type: Experimental
description: Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
arm group label: Routine-chemotherapy group
arm group type: Other
description: Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
intervention type: Device
intervention name: Chrono-chemotherapy pump:Melodie
arm group label: Melodie group
intervention type: Device
intervention name: Routine intravenous drip
arm group label: Routine-chemotherapy group
intervention type: Drug
intervention name: induction chemotherapy
arm group label: Melodie group
arm group label: Routine-chemotherapy group
intervention type: Drug
intervention name: cisplatin chrono-chemotherapy
arm group label: Melodie group
intervention type: Radiation
intervention name: intensity-modulated radiation therapy
arm group label: Melodie group
arm group label: Routine-chemotherapy group
intervention type: Drug
intervention name: cisplatin routine-chemotherapy
arm group label: Routine-chemotherapy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Feng Jin, Professor
phone: +86 13985124806
email: jinf8865@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Guiyang Medical University
investigator full name: Feng Jing
investigator title: Guiyang Medical College
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Cisplatin