<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/NCT01689558</url>
  </required_header>
  <id_info>
    <org_study_id>20111220</org_study_id>
    <nct_id>NCT01689558</nct_id>
  </id_info>
  <brief_title>Recombine Endostatin With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Advanced Nasopharynx Cancer</brief_title>
  <official_title>Recombine Endostatin in Alliance With Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jin Feng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Hospital of Guizhou Province</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance&#xD;
      with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced&#xD;
      nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined&#xD;
      Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to&#xD;
      treat the local advanced nasopharyngeal darcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. experimental group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human&#xD;
           endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles;followed&#xD;
           by concurrent chemoradiation(Cisplatin 80mg/m2 iv in day 1,21 +human endostatin 7.5mg/m2&#xD;
           iv in day 1-14 and Concurrent Intensity-modulated radiation therapy)&#xD;
&#xD;
        2. Control group:group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 and&#xD;
           three weeks repeat and total two cycles;followed by concurrent chemoradiation(Cisplatin&#xD;
           80mg/m2 iv in day 1,21 and Concurrent Intensity-modulated radiation therapy)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>main objective</measure>
    <time_frame>at the end of the Radiation</time_frame>
    <description>observe and compare the curative effect of endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma&#xD;
evaluate the security and tolerability in endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>1、Enough Cases</condition>
  <condition>2、Elekta Precise 1343 Digital Control Electron Linear Accelerator</condition>
  <condition>Can Undertake Nasopharyngeal Carcinoma Specimens in the Materia，</condition>
  <condition>Image Department of Nose Pharynx Ministry MRI Dynamic Testing,</condition>
  <arm_group>
    <arm_group_label>Recombine Endostatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction chemotherapy:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles Synchronous chemotherapy: cisplatin 80 mg/m2 points d1-2, 21days for a cycle, 2 cycles, the same day in radiation therapy. Synchronous chemotherapy in chemotherapy day one recombinant human vascular endothelial inhibin 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombine Endostatin</intervention_name>
    <description>Recombine Endostatin is involved in the arm of Recombine Endostatin .Recombinant human vascular endothelial inhibin 7.5 mg/M2 / d dose add 250 ml of physiological saline, dilute in new adjuvant chemotherapy began to 8-21 days intravenous drip, at least 1 hour, a total of 1 cycle; The chemoradiation in cisplatin chemotherapy first day grace degrees 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment</description>
    <arm_group_label>Recombine Endostatin</arm_group_label>
    <other_name>recombinant human vascular endothelial inhibin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary and sign the informed consent form; 2) Age 18-70 years old, male or female;&#xD;
             3) histologically proved to be keratinizing carcinoma or non-keratinizing carcinoma;&#xD;
             4) nasopharyngeal darcinoma 2010 UICC staging III-IV A, IV B; 5) measurable Primary&#xD;
             tumors; 6) karnofsky score≥70; ECOG≥2; 7) Expected survival≥6 months; 8) Women in&#xD;
             productive age should guarantee use contraceptives during study period; 9)&#xD;
             Hemoglobin(HGB) ≥100g/L, white blood cell(WBC) ≥4×109 /L，Platelet（PLT）≥100×109 /L.（or&#xD;
             white blood cell and platelet not less than our hospital's Normal lowest index）; 10)&#xD;
             liver function: Alanine amino transferase (ALAT), aspartate aminotransferase (ASAT)&#xD;
             &lt;1.5 times the upper limit of the normal index; total bilirubin&lt;1.5×ULN; 11) liver&#xD;
             function: serum creatinine&lt;1.5×ULN; 12) do not have severe complication, such as&#xD;
             Hypertensio, Diabetes and History of mental illness; 13) this treatment is First&#xD;
             treatment process (do not have a H&amp;N Radiation history; do not have a history of&#xD;
             Concurrent chemoradiotherapy; do not have chemotherapy history in 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a distant metastasis; 2) The primary focal tumors or lymph node already had a&#xD;
             surgical treatment (except for biopsy); 3) Already had a radiotherapy for primary&#xD;
             focal or lymph node; 4) Patient who received the the epidermal growth factor targeted&#xD;
             therapy; 5) The primary focal had received chemoradiotherapy or immunotherapy; 6)&#xD;
             Patient who suffered from other malignant tumor (except for cured basal cell carcinoma&#xD;
             or carcinoma in situ of cervix); 7) Subject who have taken other drug test in 1 month;&#xD;
             8) Peripheral Neuropathy&gt; level; 9) pregnant woman or Lactating Women and Women in&#xD;
             productive age who refuse take contraception in observation period; 10) subject with a&#xD;
             severe allergic history or idiosyncratic; 11) subject with severe pulmonary and&#xD;
             cardiopathic disease history; 12) refuse or incapable to sign the informed consent&#xD;
             form of participating this trial; 13) drug abuse or alcohol addicted; 14) subject with&#xD;
             a Personality or psychiatric diseases, people with no legal capacity or people with&#xD;
             limited capacity for civil conduct.&#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>Jin Feng, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital of Guizhou Province</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Feng Jin, Professor</last_name>
    <phone>+86 13985124806</phone>
    <email>jinf8865@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital of Guizhou province</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550002</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Jin, Professor</last_name>
      <phone>+86 13985124806</phone>
      <email>jinf8865@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Feng Jin, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>March 11, 2013</last_update_submitted>
  <last_update_submitted_qc>March 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Hospital of Guizhou Province</investigator_affiliation>
    <investigator_full_name>Jin Feng</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>nasopharynx cancer,Image department of nose pharynx ministry</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>Endostatins</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/NCT01689558
org study id: 20111220
nct id: NCT01689558
lead sponsor: 
has dmc: Yes
1) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance
      with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced
      nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined
      Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to
      treat the local advanced nasopharyngeal darcinoma.
1. experimental group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human
           endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles;followed
           by concurrent chemoradiation(Cisplatin 80mg/m2 iv in day 1,21 +human endostatin 7.5mg/m2
           iv in day 1-14 and Concurrent Intensity-modulated radiation therapy)

        2. Control group:group:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 and
           three weeks repeat and total two cycles;followed by concurrent chemoradiation(Cisplatin
           80mg/m2 iv in day 1,21 and Concurrent Intensity-modulated radiation therapy)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: main objective
time frame: at the end of the Radiation
description: observe and compare the curative effect of endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma
evaluate the security and tolerability in endostatin/recombined Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma.
arm group label: Recombine Endostatin
arm group type: Experimental
description: Induction chemotherapy:docetaxel 75mg/m2 iv in day 1 +Cisplatin 80mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles Synchronous chemotherapy: cisplatin 80 mg/m2 points d1-2, 21days for a cycle, 2 cycles, the same day in radiation therapy. Synchronous chemotherapy in chemotherapy day one recombinant human vascular endothelial inhibin 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment
intervention type: Drug
intervention name: Recombine Endostatin
description: Recombine Endostatin is involved in the arm of Recombine Endostatin .Recombinant human vascular endothelial inhibin 7.5 mg/M2 / d dose add 250 ml of physiological saline, dilute in new adjuvant chemotherapy began to 8-21 days intravenous drip, at least 1 hour, a total of 1 cycle; The chemoradiation in cisplatin chemotherapy first day grace degrees 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment
arm group label: Recombine Endostatin
other name: recombinant human vascular endothelial inhibin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jin Feng, Professor
role: Principal Investigator
affiliation: Cancer Hospital of Guizhou Province
last name: Feng Jin, Professor
phone: +86 13985124806
email: jinf8865@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Cancer Hospital of Guizhou Province
investigator full name: Jin Feng
investigator title: Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Endostatins