<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/NCT03840421</url>
  </required_header>
  <id_info>
    <org_study_id>2018-FXY-140</org_study_id>
    <nct_id>NCT03840421</nct_id>
  </id_info>
  <brief_title>GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma</brief_title>
  <official_title>GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</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 the survival and toxicity of GP (gemcitabine and&#xD;
      cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with&#xD;
      concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC&#xD;
      ) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly&#xD;
      assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil)&#xD;
      induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms&#xD;
      receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles&#xD;
      during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m²&#xD;
      d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm&#xD;
      receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three&#xD;
      cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include&#xD;
      distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free&#xD;
      survival (LRRFS), initial response rates after treatments, toxic effects and quality of life&#xD;
      (QoL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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</time_frame>
    <description>Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival (DMFS)</measure>
    <time_frame>3 years</time_frame>
    <description>The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>3 years</time_frame>
    <description>The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional Relapse-Free Survival (LRRFS)</measure>
    <time_frame>3 years</time_frame>
    <description>The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Incidence of acute and late toxicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">468</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Nasopharyngeal Neoplasms</condition>
  <condition>Nasopharyngeal Diseases</condition>
  <condition>Head and Neck Neoplasm</condition>
  <arm_group>
    <arm_group_label>gemcitabine and cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cisplatin and fluorouracil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabine and cisplatin</intervention_name>
    <description>Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.</description>
    <arm_group_label>gemcitabine and cisplatin</arm_group_label>
    <other_name>gemcitabine and cisplatin (GP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin and fluorouracil</intervention_name>
    <description>Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.</description>
    <arm_group_label>cisplatin and fluorouracil</arm_group_label>
    <other_name>cisplatin and fluorouracil (PF)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT</intervention_name>
    <description>Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor</description>
    <arm_group_label>cisplatin and fluorouracil</arm_group_label>
    <arm_group_label>gemcitabine and cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.</description>
    <arm_group_label>cisplatin and fluorouracil</arm_group_label>
    <arm_group_label>gemcitabine and cisplatin</arm_group_label>
    <other_name>cisplatin（DDP）</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly histologically confirmed non-keratinizing nasopharyngeal&#xD;
             carcinoma, including WHO II or III&#xD;
&#xD;
          -  Tumor staged as T1-4N2-3/T4N0-1M0（according to the 8th AJCC edition）&#xD;
&#xD;
          -  Male and no pregnant female&#xD;
&#xD;
          -  Age between 18-65&#xD;
&#xD;
          -  Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count&#xD;
             ≥100000/μL&#xD;
&#xD;
          -  Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase&#xD;
             (AST) &lt;2.0×upper limit of normal (ULN)&#xD;
&#xD;
          -  Adequate renal function: creatinine clearance ≥60 ml/min&#xD;
&#xD;
          -  Satisfactory performance status: Karnofsky scale (KPS) ≥ 70&#xD;
&#xD;
          -  Without radiotherapy or chemotherapy&#xD;
&#xD;
          -  Patients must give signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of relapse or distant metastasis&#xD;
&#xD;
          -  History of prior malignancy or previous treatment for NPC&#xD;
&#xD;
          -  Any severe intercurrent disease, which may bring unacceptable risk or affect the&#xD;
             compliance of the trial, for example, unstable cardiac disease requiring treatment,&#xD;
             renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose&#xD;
             &gt;1.5×ULN), and emotional disturbance.&#xD;
&#xD;
          -  Pregnancy or lactation&#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>Ming-Yuan Chen, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peiyu Huang, MD,PhD</last_name>
    <phone>+86-20-87343379</phone>
    <email>huangpy@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ming-Yuan Chen, MD,PhD</last_name>
    <phone>+86-20-87343361</phone>
    <email>chenmy@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui-Hua Xu, MD,PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Ming-Yuan Chen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>gemcitabine</keyword>
  <keyword>cisplatin</keyword>
  <keyword>fluorouracil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Diseases</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>Fluorouracil</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/NCT03840421
org study id: 2018-FXY-140
nct id: NCT03840421
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and
      cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with
      concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC
      ) patients.
Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly
      assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil)
      induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms
      receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles
      during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m²
      d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm
      receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three
      cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include
      distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free
      survival (LRRFS), initial response rates after treatments, toxic effects and quality of life
      (QoL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progress-free survival (PFS)
time frame: 3 years
description: Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
measure: Distant Metastasis-Free Survival (DMFS)
time frame: 3 years
description: The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
measure: Overall Survival (OS)
time frame: 3 years
description: The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
measure: Locoregional Relapse-Free Survival (LRRFS)
time frame: 3 years
description: The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
measure: Number of participants with adverse events
time frame: up to 3 years
description: Incidence of acute and late toxicity
arm group label: gemcitabine and cisplatin
arm group type: Experimental
description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
arm group label: cisplatin and fluorouracil
arm group type: Active Comparator
description: Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
intervention type: Drug
intervention name: gemcitabine and cisplatin
description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
arm group label: gemcitabine and cisplatin
other name: gemcitabine and cisplatin (GP)
intervention type: Drug
intervention name: cisplatin and fluorouracil
description: Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
arm group label: cisplatin and fluorouracil
other name: cisplatin and fluorouracil (PF)
intervention type: Radiation
intervention name: IMRT
description: Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor
arm group label: cisplatin and fluorouracil
arm group label: gemcitabine and cisplatin
intervention type: Drug
intervention name: cisplatin
description: IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
arm group label: cisplatin and fluorouracil
arm group label: gemcitabine and cisplatin
other name: cisplatin（DDP）
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ming-Yuan Chen, MD,PhD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Peiyu Huang, MD,PhD
phone: +86-20-87343379
email: huangpy@sysucc.org.cn
last name: Ming-Yuan Chen, MD,PhD
phone: +86-20-87343361
email: chenmy@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Ming-Yuan Chen
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Nasopharyngeal Carcinoma
mesh term: Head and Neck Neoplasms
mesh term: Nasopharyngeal Neoplasms
mesh term: Nasopharyngeal Diseases
mesh term: Cisplatin
mesh term: Gemcitabine
mesh term: Fluorouracil