<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/NCT03240835</url>
  </required_header>
  <id_info>
    <org_study_id>NPC-PA/RBP/TRSF</org_study_id>
    <nct_id>NCT03240835</nct_id>
  </id_info>
  <brief_title>The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients</brief_title>
  <official_title>The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhao Chong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wu Jieping Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</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 study the function of pre-albumin, retinol conjugated protein&#xD;
      and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for&#xD;
      local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>changes of PA/RBP/TRSF</measure>
    <time_frame>baseline and during treatment</time_frame>
    <description>to evaluate the changes of PA/RBP/TRSF during the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Body weight</measure>
    <time_frame>baseline and during treatment</time_frame>
    <description>to compare the change of weight loss during treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>baseline and during treatment</time_frame>
    <description>To observe the complete blood cell count and blood biochemical examination during treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Toxicity</measure>
    <time_frame>baseline and during treatment</time_frame>
    <description>To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>CCRT±NACT</arm_group_label>
    <description>Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin and docetaxel</intervention_name>
    <description>NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles.&#xD;
CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.</description>
    <arm_group_label>CCRT±NACT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT</intervention_name>
    <description>intensity modulation radiation therapy</description>
    <arm_group_label>CCRT±NACT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic&#xD;
        diagnosis of World Health Organization(WHO) II/III&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)&#xD;
&#xD;
          -  All genders，range from 18～60 years old&#xD;
&#xD;
          -  Karnofsky performance status(KPS) ≥ 80&#xD;
&#xD;
          -  Clinical stage III~IVb(UICC 8th)&#xD;
&#xD;
          -  Without significant digestive system disease，nutritional and metabolic diseases or&#xD;
             endocrine disease&#xD;
&#xD;
          -  Without significant cardiac，respiratory，kidney or liver disease&#xD;
&#xD;
          -  Not received radiotherapy, chemotherapy and other anti-tumor treatment(including&#xD;
             immunotherapy)&#xD;
&#xD;
          -  white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L,&#xD;
             Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L&#xD;
&#xD;
          -  alanine aminotransferase (ALT) or aspartate aminotransferase(AST) &lt; 1.5×upper limit of&#xD;
             normal(ULN), bilirubin &lt; 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min&#xD;
&#xD;
          -  Inform consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distance metastases&#xD;
&#xD;
          -  Second malignancy within 5 years&#xD;
&#xD;
          -  Drug or alcohol addition&#xD;
&#xD;
          -  Do not have full capacity for civil acts&#xD;
&#xD;
          -  Active systemic infections&#xD;
&#xD;
          -  Chronic consumptions&#xD;
&#xD;
          -  Mental disorder&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Concurrent immunotherapy or hormone therapy for other diseases&#xD;
&#xD;
          -  Severe complication, eg, uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cancer Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 29, 2023</last_update_submitted>
  <last_update_submitted_qc>January 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zhao Chong</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>pre-Albumin</keyword>
  <keyword>Retinol Conjugated Protein</keyword>
  <keyword>Transferrin</keyword>
  <keyword>Locoregionally Advanced Nasopharyngeal Carcinoma</keyword>
  <keyword>nutrition</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>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</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/NCT03240835
org study id: NPC-PA/RBP/TRSF
nct id: NCT03240835
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to study the function of pre-albumin, retinol conjugated protein
      and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for
      local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.
observational model: Case-Only
time perspective: Prospective
measure: changes of PA/RBP/TRSF
time frame: baseline and during treatment
description: to evaluate the changes of PA/RBP/TRSF during the treatment
measure: Change of Body weight
time frame: baseline and during treatment
description: to compare the change of weight loss during treatment
measure: Number of Participants With Abnormal Laboratory Values
time frame: baseline and during treatment
description: To observe the complete blood cell count and blood biochemical examination during treatment
measure: Acute Toxicity
time frame: baseline and during treatment
description: To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0
arm group label: CCRT±NACT
description: Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only
intervention type: Drug
intervention name: cisplatin and docetaxel
description: NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles.
CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.
arm group label: CCRT±NACT
intervention type: Radiation
intervention name: IMRT
description: intensity modulation radiation therapy
arm group label: CCRT±NACT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhao Chong
investigator title: Clinical Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Malnutrition
mesh term: Docetaxel