<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/NCT04437329</url>
  </required_header>
  <id_info>
    <org_study_id>NPC-NDP</org_study_id>
    <nct_id>NCT04437329</nct_id>
  </id_info>
  <brief_title>Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma</brief_title>
  <official_title>Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical 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>
      To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction&#xD;
      chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced&#xD;
      nasopharyngeal carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority&#xD;
      clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in&#xD;
      induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced&#xD;
      nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as&#xD;
      induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy&#xD;
      (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen&#xD;
      combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive&#xD;
      radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free&#xD;
      survival (PFS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2029</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2028</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 randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.</description>
  </primary_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>Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis-Free Survival(DMFS)</measure>
    <time_frame>3 years</time_frame>
    <description>Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)</measure>
    <time_frame>3 years</time_frame>
    <description>Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H&amp;N35). The EORTC QLQ-H&amp;N35 scale employs a 4-point response format (&quot;not at all&quot; to &quot;very much&quot;). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>12 weeks after the interventions</time_frame>
    <description>Objective Response Rate (ORR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>12 weeks after the interventions</time_frame>
    <description>Disease Control Rate (DCR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">352</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>DNF-N</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction chemotherapy:&#xD;
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks&#xD;
Concurrent chemoradiotherapy:&#xD;
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy&#xD;
Radiotherapy: radical intense modulated radiation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DPF-P</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction chemotherapy:&#xD;
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks&#xD;
Concurrent chemoradiotherapy:&#xD;
three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy&#xD;
Radiotherapy: radical intense modulated radiation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel, nedaplatin, fluorouracil</intervention_name>
    <description>Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.</description>
    <arm_group_label>DNF-N</arm_group_label>
    <other_name>DNF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel, cisplatin, fluorouracil</intervention_name>
    <description>Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.</description>
    <arm_group_label>DPF-P</arm_group_label>
    <other_name>DPF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nedaplatin</intervention_name>
    <description>Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.</description>
    <arm_group_label>DNF-N</arm_group_label>
    <other_name>NDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.</description>
    <arm_group_label>DPF-P</arm_group_label>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity modulated-radiotherapy</intervention_name>
    <description>Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 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>DNF-N</arm_group_label>
    <arm_group_label>DPF-P</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal&#xD;
             carcinoma, including WHO II or III&#xD;
&#xD;
          2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition&#xD;
             American Joint Committee on Cancer staging system&#xD;
&#xD;
          3. No evidence of distant metastasis (M0)&#xD;
&#xD;
          4. Age between 18-65&#xD;
&#xD;
          5. WBC≥4×10^9/ l, platelet ≥ 100×10^9/ l and hemoglobin ≥ 90g/l&#xD;
&#xD;
          6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)&#xD;
&#xD;
          7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)&#xD;
&#xD;
          8. Satisfactory performance status: KARNOFSKY scale (KPS) &gt; 70&#xD;
&#xD;
          9. Patients must give signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)&#xD;
&#xD;
          2. Age &gt;65 or &lt; 18 years&#xD;
&#xD;
          3. Treatment with palliative intent&#xD;
&#xD;
          4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in&#xD;
             situ cervical cancer&#xD;
&#xD;
          5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the&#xD;
             primary tumor or nodes&#xD;
&#xD;
          6. History of previous radiotherapy&#xD;
&#xD;
          7. Pregnancy or lactation&#xD;
&#xD;
          8. 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;
             acute exacerbation of chronic obstructive pulmonary disease or other respiratory&#xD;
             illness requiring admission to hospital, active hepatitis, and mental 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>Jinquan Liu, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jinquan Liu, M.D</last_name>
    <phone>0086-137-1086-6485</phone>
    <email>609149209@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bin Qi, M.D</last_name>
    <phone>0086-135-8058-0985</phone>
    <email>qibin020@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of radiotherapy(Section 5),Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510095</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinquan Liu, M.D</last_name>
      <phone>0086-137-1086-6485</phone>
      <email>609149209@qq.com</email>
    </contact>
    <contact_backup>
      <last_name>Bin Qi, M.D</last_name>
      <phone>0086-135-8058-0985</phone>
      <email>qibin020@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jinquan Liu, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Affiliated Cancer Hospital &amp; Institute of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Jin-Quan Liu</investigator_full_name>
    <investigator_title>President of Affiliated Tumor Hospital of Guangzhou Medical University</investigator_title>
  </responsible_party>
  <keyword>induction chemotherapy</keyword>
  <keyword>nedaplatin</keyword>
  <keyword>cisplatin</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>Docetaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Nedaplatin</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/NCT04437329
org study id: NPC-NDP
nct id: NCT04437329
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction
      chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced
      nasopharyngeal carcinoma.
This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority
      clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in
      induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced
      nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as
      induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy
      (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen
      combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive
      radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free
      survival (PFS).
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 randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
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: Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.
measure: Distant metastasis-Free Survival(DMFS)
time frame: 3 years
description: Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.
measure: Quality of life (QoL)
time frame: 3 years
description: Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H&N35). The EORTC QLQ-H&N35 scale employs a 4-point response format ("not at all" to "very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits.
measure: Objective Response Rate (ORR)
time frame: 12 weeks after the interventions
description: Objective Response Rate (ORR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)
measure: Disease Control Rate (DCR)
time frame: 12 weeks after the interventions
description: Disease Control Rate (DCR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1)
arm group label: DNF-N
arm group type: Experimental
description: Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks
Concurrent chemoradiotherapy:
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy
Radiotherapy: radical intense modulated radiation therapy
arm group label: DPF-P
arm group type: Active Comparator
description: Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks
Concurrent chemoradiotherapy:
three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy
Radiotherapy: radical intense modulated radiation therapy
intervention type: Drug
intervention name: Docetaxel, nedaplatin, fluorouracil
description: Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
arm group label: DNF-N
other name: DNF
intervention type: Drug
intervention name: Docetaxel, cisplatin, fluorouracil
description: Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
arm group label: DPF-P
other name: DPF
intervention type: Drug
intervention name: Nedaplatin
description: Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
arm group label: DNF-N
other name: NDP
intervention type: Drug
intervention name: Cisplatin
description: Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
arm group label: DPF-P
other name: DDP
intervention type: Radiation
intervention name: Intensity modulated-radiotherapy
description: Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 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: DNF-N
arm group label: DPF-P
other name: IMRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jinquan Liu, M.D
role: Study Director
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
last name: Jinquan Liu, M.D
phone: 0086-137-1086-6485
email: 609149209@qq.com
last name: Bin Qi, M.D
phone: 0086-135-8058-0985
email: qibin020@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
investigator full name: Jin-Quan Liu
investigator title: President of Affiliated Tumor Hospital of Guangzhou Medical University
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Cisplatin
mesh term: Docetaxel
mesh term: Fluorouracil
mesh term: Nedaplatin
sharing ipd: No