<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/NCT03020329</url>
  </required_header>
  <id_info>
    <org_study_id>NPC in Young Patients</org_study_id>
    <nct_id>NCT03020329</nct_id>
  </id_info>
  <brief_title>Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma</brief_title>
  <official_title>Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy&#xD;
      works in treating children with advanced nasopharyngeal carcinoma(NPC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase II trial is studying how well radiation therapy and chemotherapy work in treating&#xD;
      young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy&#xD;
      x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil&#xD;
      and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing&#xD;
      the cells or by stopping them from dividing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Response (CR)</measure>
    <time_frame>After the completion of the chemoradiotherapy treatment (up to 9 weeks)</time_frame>
    <description>CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>3-year</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>Progress-free survival(PFS)</measure>
    <time_frame>3-year</time_frame>
    <description>Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional failure-free survival(LRFS)</measure>
    <time_frame>3-year</time_frame>
    <description>The LRFS 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>Distant metastasis-free survival(DMFS)</measure>
    <time_frame>3-year</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>Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)</measure>
    <time_frame>3 months</time_frame>
    <description>The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term toxicities</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term toxicities</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>EORTC quality of life questionnaire(QLQ) Head and Neck</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>Patients will be monitored for height(in metre)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>Patients will be monitored for weight(in kilogram)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>Patients will be monitored for BMI(in kg/m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex Development</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>Sex hormone(estrogen,testosterone) levels(in nmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex Development</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>Secondary sex characteristic survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intelligence Development</measure>
    <time_frame>Through study completion, an average of half year</time_frame>
    <description>Intelligence quotient by Stanford-Binet test</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Paclitaxel liposome, Cisplatin, 5-Fu,</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel liposome</intervention_name>
    <description>Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy.&#xD;
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.&#xD;
Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily.</description>
    <arm_group_label>Paclitaxel liposome, Cisplatin, 5-Fu,</arm_group_label>
    <other_name>Paclitaxel liposome,cisplatin,fluorouracil(TPF) chemotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.</description>
    <arm_group_label>Paclitaxel liposome, Cisplatin, 5-Fu,</arm_group_label>
    <other_name>TPF induction chemotherapy</other_name>
    <other_name>Concurrent cisplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-fu</intervention_name>
    <description>Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.</description>
    <arm_group_label>Paclitaxel liposome, Cisplatin, 5-Fu,</arm_group_label>
    <other_name>TPF induction chemotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radical radiotherapy</intervention_name>
    <description>Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.</description>
    <arm_group_label>Paclitaxel liposome, Cisplatin, 5-Fu,</arm_group_label>
    <other_name>Concurrent radiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly histologically confirmed non-keratinizing (according to World&#xD;
             Health Organization (WHO) histologically type).&#xD;
&#xD;
          -  Original clinical staged as T4N0-3 M0 or any T、N3M0（according to the American Joint&#xD;
             Committee on Cancer(AJCC) 7th edition）&#xD;
&#xD;
          -  No evidence of distant metastasis (M0).&#xD;
&#xD;
          -  Age ≤ 18 years old.&#xD;
&#xD;
          -  Satisfactory performance status: Karnofsky scale (KPS) &gt; 70.&#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;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;
          -  Patients must be informed of the investigational nature of this study and give written&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  Treatment with palliative intent.&#xD;
&#xD;
          -  Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in&#xD;
             situ cervical cancer.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  History of previous radiotherapy (except for non-melanomatous skin cancers outside&#xD;
             intended RT treatment volume).&#xD;
&#xD;
          -  Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.&#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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HaiQiang Mai, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>DongHua Luo, MD,PhD</last_name>
    <phone>8620-87343643</phone>
    <email>luodh@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HaiQiang Mai, PhD</last_name>
      <phone>8620-38606186</phone>
      <email>maihq@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp</url>
    <description>cisplatin</description>
  </link>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp</url>
    <description>amifostine</description>
  </link>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp</url>
    <description>paclitaxel</description>
  </link>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp</url>
    <description>fluorouracil</description>
  </link>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/</url>
    <description>nasopharyngeal carcinoma</description>
  </link>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/</url>
    <description>young patients</description>
  </link>
  <reference>
    <citation>Daoud J, Ghorbal L, Siala W, Elloumi F, Ghorbel A, Frikha M. [Is there any difference in therapeutic results of nasopharyngeal carcinoma between adults and children?]. Cancer Radiother. 2013 Dec;17(8):763-7. doi: 10.1016/j.canrad.2013.06.046. Epub 2013 Nov 20. French.</citation>
    <PMID>24269016</PMID>
  </reference>
  <reference>
    <citation>Yan Z, Xia L, Huang Y, Chen P, Jiang L, Zhang B. Nasopharyngeal carcinoma in children and adolescents in an endemic area: a report of 185 cases. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1454-60. doi: 10.1016/j.ijporl.2013.06.005. Epub 2013 Jul 3.</citation>
    <PMID>23830224</PMID>
  </reference>
  <reference>
    <citation>Liao WW, Tang SQ, Liu Y, Feng C. [Treatment of nasopharyngeal carcinoma in children]. Zhongguo Dang Dai Er Ke Za Zhi. 2013 Apr;15(4):273-6. Chinese.</citation>
    <PMID>23607949</PMID>
  </reference>
  <reference>
    <citation>Hu S, Xu X, Xu J, Xu Q, Liu S. Prognostic factors and long-term outcomes of nasopharyngeal carcinoma in children and adolescents. Pediatr Blood Cancer. 2013 Jul;60(7):1122-7. doi: 10.1002/pbc.24458. Epub 2013 Jan 9.</citation>
    <PMID>23303571</PMID>
  </reference>
  <reference>
    <citation>Cheuk DK, Billups CA, Martin MG, Roland CR, Ribeiro RC, Krasin MJ, Rodriguez-Galindo C. Prognostic factors and long-term outcomes of childhood nasopharyngeal carcinoma. Cancer. 2011 Jan 1;117(1):197-206. doi: 10.1002/cncr.25376. Epub 2010 Aug 24.</citation>
    <PMID>20737561</PMID>
  </reference>
  <reference>
    <citation>Buehrlen M, Zwaan CM, Granzen B, Lassay L, Deutz P, Vorwerk P, Staatz G, Gademann G, Christiansen H, Oldenburger F, Tamm M, Mertens R. Multimodal treatment, including interferon beta, of nasopharyngeal carcinoma in children and young adults: preliminary results from the prospective, multicenter study NPC-2003-GPOH/DCOG. Cancer. 2012 Oct 1;118(19):4892-900. doi: 10.1002/cncr.27395. Epub 2012 Feb 22.</citation>
    <PMID>22359313</PMID>
  </reference>
  <reference>
    <citation>Shen C, Gao Y, Xu T, Wang X, Ying H, Hu C. Carcinoma of the nasopharynx in young patients: a single institution experience. Clin Oncol (R Coll Radiol). 2009 Oct;21(8):617-22. doi: 10.1016/j.clon.2009.07.005. Epub 2009 Aug 5.</citation>
    <PMID>19660923</PMID>
  </reference>
  <reference>
    <citation>Varan A, Ozyar E, Corapcioglu F, Koksal Y, Aydin B, Yazici N, Akyuz C, Buyukpamukcu M. Pediatric and young adult nasopharyngeal carcinoma patients treated with preradiation Cisplatin and docetaxel chemotherapy. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1116-20. doi: 10.1016/j.ijrobp.2008.05.028. Epub 2008 Sep 9.</citation>
    <PMID>18786778</PMID>
  </reference>
  <reference>
    <citation>Laskar S, Bahl G, Muckaden M, Pai SK, Gupta T, Banavali S, Arora B, Sharma D, Kurkure PA, Ramadwar M, Viswanathan S, Rangarajan V, Qureshi S, Deshpande DD, Shrivastava SK, Dinshaw KA. Nasopharyngeal carcinoma in children: comparison of conventional and intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):728-36. doi: 10.1016/j.ijrobp.2008.01.032. Epub 2008 Apr 18.</citation>
    <PMID>18374512</PMID>
  </reference>
  <reference>
    <citation>Selek U, Ozyar E, Ozyigit G, Varan A, Buyukpamukcu M, Atahan IL. Treatment results of 59 young patients with nasopharyngeal carcinoma. Int J Pediatr Otorhinolaryngol. 2005 Feb;69(2):201-7. doi: 10.1016/j.ijporl.2004.09.001.</citation>
    <PMID>15656953</PMID>
  </reference>
  <reference>
    <citation>Orbach D, Brisse H, Helfre S, Klijanienko J, Bours D, Mosseri V, Rodriguez J. Radiation and chemotherapy combination for nasopharyngeal carcinoma in children: Radiotherapy dose adaptation after chemotherapy response to minimize late effects. Pediatr Blood Cancer. 2008 Apr;50(4):849-53. doi: 10.1002/pbc.21372.</citation>
    <PMID>17973328</PMID>
  </reference>
  <reference>
    <citation>Ahern V, Jenkin D, Banerjee D, Greenberg M, Payne D. Nasopharyngeal carcinoma in the young. Clin Oncol (R Coll Radiol). 1994;6(1):24-30. doi: 10.1016/s0936-6555(05)80364-4.</citation>
    <PMID>8172830</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Hai-Qiang Mai,MD,PhD</investigator_full_name>
    <investigator_title>Professor and Deputy Director</investigator_title>
  </responsible_party>
  <keyword>Induction Chemotherapy</keyword>
  <keyword>Nasopharyngeal carcinoma</keyword>
  <keyword>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>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</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/NCT03020329
org study id: NPC in Young Patients
nct id: NCT03020329
lead sponsor: 
has dmc: Yes
1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy
      works in treating children with advanced nasopharyngeal carcinoma(NPC).
This phase II trial is studying how well radiation therapy and chemotherapy work in treating
      young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy
      x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil
      and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Response (CR)
time frame: After the completion of the chemoradiotherapy treatment (up to 9 weeks)
description: CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only
measure: Overall survival(OS)
time frame: 3-year
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: Progress-free survival(PFS)
time frame: 3-year
description: Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
measure: Locoregional failure-free survival(LRFS)
time frame: 3-year
description: The LRFS 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: Distant metastasis-free survival(DMFS)
time frame: 3-year
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: Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
time frame: 3 months
description: The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
measure: Long-term toxicities
time frame: Through study completion, an average of half year
description: QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)
measure: Long-term toxicities
time frame: Through study completion, an average of half year
description: EORTC quality of life questionnaire(QLQ) Head and Neck
measure: Growth
time frame: Through study completion, an average of half year
description: Patients will be monitored for height(in metre)
measure: Growth
time frame: Through study completion, an average of half year
description: Patients will be monitored for weight(in kilogram)
measure: Growth
time frame: Through study completion, an average of half year
description: Patients will be monitored for BMI(in kg/m^2)
measure: Sex Development
time frame: Through study completion, an average of half year
description: Sex hormone(estrogen,testosterone) levels(in nmol/L)
measure: Sex Development
time frame: Through study completion, an average of half year
description: Secondary sex characteristic survey
measure: Intelligence Development
time frame: Through study completion, an average of half year
description: Intelligence quotient by Stanford-Binet test
arm group label: Paclitaxel liposome, Cisplatin, 5-Fu,
arm group type: Experimental
description: Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
intervention type: Drug
intervention name: Paclitaxel liposome
description: Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy.
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily.
arm group label: Paclitaxel liposome, Cisplatin, 5-Fu,
other name: Paclitaxel liposome,cisplatin,fluorouracil(TPF) chemotherapy
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.
arm group label: Paclitaxel liposome, Cisplatin, 5-Fu,
other name: TPF induction chemotherapy
other name: Concurrent cisplatin
intervention type: Drug
intervention name: 5-fu
description: Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.
arm group label: Paclitaxel liposome, Cisplatin, 5-Fu,
other name: TPF induction chemotherapy
intervention type: Radiation
intervention name: Radical radiotherapy
description: Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.
arm group label: Paclitaxel liposome, Cisplatin, 5-Fu,
other name: Concurrent radiotherapy
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: HaiQiang Mai, MD,PhD
role: Principal Investigator
affiliation: Cancer center
last name: DongHua Luo, MD,PhD
phone: 8620-87343643
email: luodh@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
url: http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
description: cisplatin
url: http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
description: amifostine
url: http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
description: paclitaxel
url: http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
description: fluorouracil
url: http://www.nlm.nih.gov/medlineplus/
description: nasopharyngeal carcinoma
url: http://www.nlm.nih.gov/medlineplus/
description: young patients
citation: Daoud J, Ghorbal L, Siala W, Elloumi F, Ghorbel A, Frikha M. [Is there any difference in therapeutic results of nasopharyngeal carcinoma between adults and children?]. Cancer Radiother. 2013 Dec;17(8):763-7. doi: 10.1016/j.canrad.2013.06.046. Epub 2013 Nov 20. French.
PMID: 24269016
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PMID: 23830224
citation: Liao WW, Tang SQ, Liu Y, Feng C. [Treatment of nasopharyngeal carcinoma in children]. Zhongguo Dang Dai Er Ke Za Zhi. 2013 Apr;15(4):273-6. Chinese.
PMID: 23607949
citation: Hu S, Xu X, Xu J, Xu Q, Liu S. Prognostic factors and long-term outcomes of nasopharyngeal carcinoma in children and adolescents. Pediatr Blood Cancer. 2013 Jul;60(7):1122-7. doi: 10.1002/pbc.24458. Epub 2013 Jan 9.
PMID: 23303571
citation: Cheuk DK, Billups CA, Martin MG, Roland CR, Ribeiro RC, Krasin MJ, Rodriguez-Galindo C. Prognostic factors and long-term outcomes of childhood nasopharyngeal carcinoma. Cancer. 2011 Jan 1;117(1):197-206. doi: 10.1002/cncr.25376. Epub 2010 Aug 24.
PMID: 20737561
citation: Buehrlen M, Zwaan CM, Granzen B, Lassay L, Deutz P, Vorwerk P, Staatz G, Gademann G, Christiansen H, Oldenburger F, Tamm M, Mertens R. Multimodal treatment, including interferon beta, of nasopharyngeal carcinoma in children and young adults: preliminary results from the prospective, multicenter study NPC-2003-GPOH/DCOG. Cancer. 2012 Oct 1;118(19):4892-900. doi: 10.1002/cncr.27395. Epub 2012 Feb 22.
PMID: 22359313
citation: Shen C, Gao Y, Xu T, Wang X, Ying H, Hu C. Carcinoma of the nasopharynx in young patients: a single institution experience. Clin Oncol (R Coll Radiol). 2009 Oct;21(8):617-22. doi: 10.1016/j.clon.2009.07.005. Epub 2009 Aug 5.
PMID: 19660923
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PMID: 18786778
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PMID: 18374512
citation: Selek U, Ozyar E, Ozyigit G, Varan A, Buyukpamukcu M, Atahan IL. Treatment results of 59 young patients with nasopharyngeal carcinoma. Int J Pediatr Otorhinolaryngol. 2005 Feb;69(2):201-7. doi: 10.1016/j.ijporl.2004.09.001.
PMID: 15656953
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PMID: 17973328
citation: Ahern V, Jenkin D, Banerjee D, Greenberg M, Payne D. Nasopharyngeal carcinoma in the young. Clin Oncol (R Coll Radiol). 1994;6(1):24-30. doi: 10.1016/s0936-6555(05)80364-4.
PMID: 8172830
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Hai-Qiang Mai,MD,PhD
investigator title: Professor and Deputy Director
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Cisplatin
mesh term: Fluorouracil
sharing ipd: No