<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/NCT02973386</url>
  </required_header>
  <id_info>
    <org_study_id>CCRT-AC-HRDM-NPC</org_study_id>
    <nct_id>NCT02973386</nct_id>
  </id_info>
  <brief_title>Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients</brief_title>
  <official_title>Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This is a randomized,controlled,prospective phase III clinical trial. The purpose of this&#xD;
      study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with&#xD;
      or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma&#xD;
      at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan&#xD;
      which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques&#xD;
      for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2025</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>Distant metastasis-free survival</measure>
    <time_frame>Five year</time_frame>
    <description>Defined as the time from date of recruitment to documented distant metastasis or death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure-free survival</measure>
    <time_frame>Five year</time_frame>
    <description>Defined as the time from date of recruitment to documented relapse or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional relapse-free survival</measure>
    <time_frame>Five year</time_frame>
    <description>Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Five year</time_frame>
    <description>Defined as the time from date of recruitment to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute toxicity</measure>
    <time_frame>three months after corresponding treatment</time_frame>
    <description>Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late toxicity</measure>
    <time_frame>Five year</time_frame>
    <description>Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">278</enrollment>
  <condition>Local Advanced High Risk Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Concurrent chemoradiation + adjuvant chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concurrent chemoradiation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IMRT combine with cisplatin concurrent chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IMRT combine with cisplatin concurrent chemotherapy</intervention_name>
    <description>Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.</description>
    <arm_group_label>Concurrent chemoradiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy</intervention_name>
    <description>Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.</description>
    <arm_group_label>Concurrent chemoradiation + adjuvant chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)&#xD;
&#xD;
          -  Clinical stage III~IVb(UICC/AJCC 7th)&#xD;
&#xD;
          -  No distant metastasis&#xD;
&#xD;
          -  Karnofsky Performance Status Scale≥70&#xD;
&#xD;
          -  WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L,&#xD;
             platelet count ≥ 100×109/L&#xD;
&#xD;
          -  ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine&#xD;
             clearance≥60ml/min&#xD;
&#xD;
          -  Sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell&#xD;
             carcinomas&#xD;
&#xD;
          -  Younger than 18 years old or older than 70 years old&#xD;
&#xD;
          -  Are receiving other drugs treanment&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  Have suffered from other tumor or now suffering from other tumor&#xD;
&#xD;
          -  Have recieved chemotherapy or radiotherapy&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  unstable heart disease need timely treatment&#xD;
&#xD;
          -  Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhao chong, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>miao jingjing</last_name>
    <phone>+86-13631355201</phone>
    <email>miaojj@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>wu haijun</last_name>
    <phone>+86-18819200847</phone>
    <email>wuhj@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhao chong, M.D</last_name>
      <phone>+86-13902206160</phone>
      <email>zhaochong@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.sysucc.org.cn</url>
    <description>Home Page of Cancer Center, Sun Yat-sen University</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>April 9, 2022</last_update_submitted>
  <last_update_submitted_qc>April 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 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>Zhao Chong</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Local advanced</keyword>
  <keyword>High Risk</keyword>
  <keyword>Nasopharyngeal Carcinoma</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>Capecitabine</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/NCT02973386
org study id: CCRT-AC-HRDM-NPC
nct id: NCT02973386
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized,controlled,prospective phase III clinical trial. The purpose of this
      study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with
      or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma
      at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan
      which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques
      for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Distant metastasis-free survival
time frame: Five year
description: Defined as the time from date of recruitment to documented distant metastasis or death from any cause.
measure: Failure-free survival
time frame: Five year
description: Defined as the time from date of recruitment to documented relapse or death from any cause.
measure: Locoregional relapse-free survival
time frame: Five year
description: Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
measure: Overall survival
time frame: Five year
description: Defined as the time from date of recruitment to death from any cause.
measure: Acute toxicity
time frame: three months after corresponding treatment
description: Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.
measure: Late toxicity
time frame: Five year
description: Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.
arm group label: Concurrent chemoradiation + adjuvant chemotherapy
arm group type: Experimental
description: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
arm group label: Concurrent chemoradiation
arm group type: Active Comparator
description: IMRT combine with cisplatin concurrent chemotherapy
intervention type: Drug
intervention name: IMRT combine with cisplatin concurrent chemotherapy
description: Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.
arm group label: Concurrent chemoradiation
intervention type: Drug
intervention name: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
description: Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.
arm group label: Concurrent chemoradiation + adjuvant chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: zhao chong, M.D
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: miao jingjing
phone: +86-13631355201
email: miaojj@sysucc.org.cn
last name: wu haijun
phone: +86-18819200847
email: wuhj@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
url: http://www.sysucc.org.cn
description: Home Page of Cancer Center, Sun Yat-sen University
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhao Chong
investigator title: MD
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Cisplatin
mesh term: Capecitabine