<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/NCT04414566</url>
  </required_header>
  <id_info>
    <org_study_id>2020HXFH037</org_study_id>
    <nct_id>NCT04414566</nct_id>
  </id_info>
  <brief_title>Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma</brief_title>
  <official_title>Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy&#xD;
      alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with&#xD;
      locoregionally advanced nasopharyngeal carcinoma (LA-NPC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 30, 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>Disease-free survival</measure>
    <time_frame>3-year</time_frame>
    <description>Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3-year</time_frame>
    <description>Overall survival is calculated from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional recurrence-free survival</measure>
    <time_frame>3-year</time_frame>
    <description>Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-free survival</measure>
    <time_frame>3-year</time_frame>
    <description>Distant metastasis-free survival is calculated from randomization to the first remote metastases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rates after treatments</measure>
    <time_frame>At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Every week during treatment, up to 4 weeks after treatment.</time_frame>
    <description>Incidence of acute toxicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">562</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>IC plus RT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IC plus CCRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil</intervention_name>
    <description>Patients receive GP gemcitabine (1000 mg/m^2 d1,8) and cisplatin (80mg/m^2 d1) or TPF docetaxel (60mg/m^2 on day 1), cisplatin (60mg/m^2 on day 1) and fluorouracil (600mg/m^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.</description>
    <arm_group_label>IC plus CCRT</arm_group_label>
    <arm_group_label>IC plus RT</arm_group_label>
    <other_name>GP;TPF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT</intervention_name>
    <description>Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.</description>
    <arm_group_label>IC plus RT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT and concurrent cisplatin</intervention_name>
    <description>Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m^2 every 3 weeks for 3 cycles.</description>
    <arm_group_label>IC plus CCRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma&#xD;
             (differentiated or undifferentiated, ie WHO type II or III).&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 65 years old.&#xD;
&#xD;
          -  Tumor staged as III/IVa (according to the 8th AJCC edition).&#xD;
&#xD;
          -  No evidence of distant metastasis (M0).&#xD;
&#xD;
          -  Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.&#xD;
&#xD;
          -  Adequate marrow: White blood cells (WBC) ≥ 4 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L,&#xD;
             platelets (PLT) ≥ 100 × 10^9/L (or within the normal range of the laboratory)&#xD;
&#xD;
          -  Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase&#xD;
             (AST) &lt; 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤&#xD;
             2.5×ULN, and bilirubin ≤ ULN.&#xD;
&#xD;
          -  Adequate renal function: creatinine clearance ≥ 60 ml/min.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.&#xD;
&#xD;
          -  Age &gt; 65 or &lt; 18.&#xD;
&#xD;
          -  Treatment with palliative intent.&#xD;
&#xD;
          -  Previous history of malignant tumors, well-treated basal cell carcinoma or squamous&#xD;
             cell carcinoma and cervical carcinoma in situ outer.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  History of previous RT (except for non-melanomatous skin cancers outside intended RT&#xD;
             treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or&#xD;
             nodes.&#xD;
&#xD;
          -  Any other serious diseases, which may bring greater risk or affect the compliance of&#xD;
             the test, for example, unstable cardiac disease requiring treatment, renal disease,&#xD;
             chronic hepatitis, diabetes with poor control (fasting plasma glucose &gt; 1.5×ULN), and&#xD;
             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>Xingchen Peng, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xingchen Peng, MD, PhD</last_name>
    <phone>+86 18980606753</phone>
    <email>pxx2014@scu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xingchen Peng</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Xingchen Peng</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Nasopharyngeal Carcinoma</keyword>
  <keyword>Induction Chemotherapy</keyword>
  <keyword>Concurrent 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>Cisplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04414566
org study id: 2020HXFH037
nct id: NCT04414566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy
      alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with
      locoregionally advanced nasopharyngeal carcinoma (LA-NPC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: 3-year
description: Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
measure: Overall survival
time frame: 3-year
description: Overall survival is calculated from randomization to death from any cause.
measure: Locoregional recurrence-free survival
time frame: 3-year
description: Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence.
measure: Distant metastasis-free survival
time frame: 3-year
description: Distant metastasis-free survival is calculated from randomization to the first remote metastases.
measure: Objective response rates after treatments
time frame: At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy
measure: Number of participants with adverse events
time frame: Every week during treatment, up to 4 weeks after treatment.
description: Incidence of acute toxicity
arm group label: IC plus RT
arm group type: Experimental
description: Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy.
arm group label: IC plus CCRT
arm group type: Active Comparator
description: Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.
intervention type: Drug
intervention name: gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil
description: Patients receive GP gemcitabine (1000 mg/m^2 d1,8) and cisplatin (80mg/m^2 d1) or TPF docetaxel (60mg/m^2 on day 1), cisplatin (60mg/m^2 on day 1) and fluorouracil (600mg/m^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
arm group label: IC plus CCRT
arm group label: IC plus RT
other name: GP;TPF
intervention type: Radiation
intervention name: IMRT
description: Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
arm group label: IC plus RT
intervention type: Radiation
intervention name: IMRT and concurrent cisplatin
description: Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m^2 every 3 weeks for 3 cycles.
arm group label: IC plus CCRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xingchen Peng, MD, PhD
role: Principal Investigator
affiliation: West China Hospital
last name: Xingchen Peng, MD, PhD
phone: +86 18980606753
email: pxx2014@scu.edu.cn
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Xingchen Peng
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Cisplatin
mesh term: Gemcitabine
mesh term: Docetaxel
mesh term: Fluorouracil
sharing ipd: No