<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/NCT03015727</url>
  </required_header>
  <id_info>
    <org_study_id>ZhejiangCH 01536224</org_study_id>
    <nct_id>NCT03015727</nct_id>
  </id_info>
  <brief_title>Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma</brief_title>
  <acronym>IRCNPC</acronym>
  <official_title>Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Central Hospital of Lishui City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinhua Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo Medical Center Lihuili Eastern Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Quzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aim to compare the progression-free survival (PFS) and side&#xD;
      effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally&#xD;
      advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete&#xD;
      response or partial response) after neoadjuvant chemotherapy (NACT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators aim to compare the survival outcomes and side effects of&#xD;
      radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced&#xD;
      nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response&#xD;
      or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin&#xD;
      treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>3 years after the inception assignment</time_frame>
    <description>PFS means assignment to the date of any local or distant progress of the disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>3 years and 5 years after the inception of the assignment</time_frame>
    <description>The overall survival denote to assignment to date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years</time_frame>
    <description>Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Locally Advanced Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>IC+RT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IC+CCRT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.</description>
    <arm_group_label>IC+CCRT group</arm_group_label>
    <arm_group_label>IC+RT group</arm_group_label>
    <other_name>DOC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.</description>
    <arm_group_label>IC+CCRT group</arm_group_label>
    <arm_group_label>IC+RT group</arm_group_label>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT/TOMO</intervention_name>
    <description>intensity modulated radiation therapy or tomotherapy</description>
    <arm_group_label>IC+CCRT group</arm_group_label>
    <arm_group_label>IC+RT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.</description>
    <arm_group_label>IC+CCRT group</arm_group_label>
    <other_name>concurrent chemotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with newly histologically confirmed non-keratinizing carcinoma.&#xD;
&#xD;
          2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)&#xD;
&#xD;
          3. No evidence of distant metastasis (M0)&#xD;
&#xD;
          4. Performance status: KPS&gt;70&#xD;
&#xD;
          5. With normal liver function test (ALT, AST &lt;1.5ULN)&#xD;
&#xD;
          6. Renal: creatinine clearance &gt;60ml/min&#xD;
&#xD;
          7. Without hematopathy,marrow: WBC &gt;4*109/L, HGB&gt;80G/L, and PLT&gt;100*109/L.&#xD;
&#xD;
          8. With controlled blood glucose for diabetes patients&#xD;
&#xD;
          9. Written informed consent&#xD;
&#xD;
         10. satisfactory tumor response (complete response or partial response) after neoadjuvant&#xD;
             chemotherapy (NACT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. WHO type I squamous cell carcinoma or adenocarcinoma&#xD;
&#xD;
          2. Age &gt;65 or &lt;18&#xD;
&#xD;
          3. With a history of renal disease&#xD;
&#xD;
          4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or&#xD;
             basal/squamous cell carcinoma of the skin)&#xD;
&#xD;
          5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside&#xD;
             the intended RT treatment volume)&#xD;
&#xD;
          6. Patient is pregnant or lactating&#xD;
&#xD;
          7. Peripheral neuropathy&#xD;
&#xD;
          8. Emotional disturbance&#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>Xiaozhong Chen</last_name>
    <role>Study Chair</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaozhong Chen</last_name>
    <email>cxzfyun@sina.com</email>
  </overall_contact>
  <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>December 2016</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nasopharyngeal carcinoma</keyword>
  <keyword>Induction chemotherapy</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>chemoradiotherapy</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>Docetaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03015727
org study id: ZhejiangCH 01536224
nct id: NCT03015727
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
In this study, the investigators aim to compare the progression-free survival (PFS) and side
      effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally
      advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete
      response or partial response) after neoadjuvant chemotherapy (NACT).
In this study, the investigators aim to compare the survival outcomes and side effects of
      radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced
      nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response
      or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin
      treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress Free Survival (PFS)
time frame: 3 years after the inception assignment
description: PFS means assignment to the date of any local or distant progress of the disease.
measure: Overall Survival (OS)
time frame: 3 years and 5 years after the inception of the assignment
description: The overall survival denote to assignment to date of death from any cause.
measure: Adverse Events
time frame: Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years
description: Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up.
arm group label: IC+RT group
arm group type: Experimental
description: 3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
arm group label: IC+CCRT group
arm group type: Active Comparator
description: 3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
intervention type: Drug
intervention name: Docetaxel
description: 3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
arm group label: IC+CCRT group
arm group label: IC+RT group
other name: DOC
intervention type: Drug
intervention name: Cisplatin
description: 3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
arm group label: IC+CCRT group
arm group label: IC+RT group
other name: DDP
intervention type: Radiation
intervention name: IMRT/TOMO
description: intensity modulated radiation therapy or tomotherapy
arm group label: IC+CCRT group
arm group label: IC+RT group
intervention type: Drug
intervention name: Chemotherapy
description: 2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
arm group label: IC+CCRT group
other name: concurrent chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xiaozhong Chen
role: Study Chair
affiliation: Zhejiang Cancer Hospital
last name: Xiaozhong Chen
email: cxzfyun@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Docetaxel
sharing ipd: Undecided