<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/NCT03791944</url>
  </required_header>
  <id_info>
    <org_study_id>XQonc-010</org_study_id>
    <nct_id>NCT03791944</nct_id>
  </id_info>
  <brief_title>3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma</brief_title>
  <official_title>3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinqiao Hospital of Chongqing</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to&#xD;
      existing domestic TPS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing&#xD;
      imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled.&#xD;
      The primary endpoint of the study was the objective response rate (ORR), and the secondary&#xD;
      endpoint was the local control rate and the incidence of treatment-related side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2019</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>3 months follow-up after treatment</time_frame>
    <description>Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local control rate</measure>
    <time_frame>3 months follow-up after treatment</time_frame>
    <description>Local control means that the tumor does not increase in imaging, but if the tumor does not increase, the patient with increased symptoms after treatment is not included in the local control range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of treatment-related side effects</measure>
    <time_frame>3 months follow-up after treatment</time_frame>
    <description>Incidence of related side effects during disease treatment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Nasopharynx Cancer</condition>
  <condition>Radiotherapy</condition>
  <arm_group>
    <arm_group_label>3DV+TPS/VARIAN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TPS/VARIAN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use imported Varian TPS to map targets and develop treatment plans.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3DV+TPS/ Domestic accelerator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use 3DV+TPS to map targets and develop treatment plans.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TPS/ Domestic accelerator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adopt domestic TPS hook target and develop treatment plan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3DV+TPS/VARIAN</intervention_name>
    <description>Use imported 3DV+TPS to map targets and develop treatment plans</description>
    <arm_group_label>3DV+TPS/VARIAN</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TPS / VARIAN</intervention_name>
    <description>Use imported TPS to map targets and develop treatment plans</description>
    <arm_group_label>TPS/VARIAN</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3DV + TPS / Domestic Accelerator</intervention_name>
    <description>Use domestic 3DV+TPS to delineate target areas and develop treatment plans</description>
    <arm_group_label>3DV+TPS/ Domestic accelerator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TPS / Domestic Accelerator</intervention_name>
    <description>Use domestic TPS to map targets and develop treatment plans</description>
    <arm_group_label>TPS/ Domestic accelerator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Consolidate other serious diseases that affect quality of life or treatment;&#xD;
&#xD;
          2. Reluctant to actively cooperate with the investigator;&#xD;
&#xD;
          3. Mergers with distant transfers;&#xD;
&#xD;
          4. Patients who have undergone head and neck surgery and radiotherapy;&#xD;
&#xD;
          5. Subjects who are affected by the disease who sign a written informed consent or follow&#xD;
             the study procedure; or who are unwilling or unable to comply with the research&#xD;
             requirements.&#xD;
&#xD;
          6. Those who have a history of psychotropic substance abuse who are unable to quit or&#xD;
             have a mental disorder;&#xD;
&#xD;
          7. Participated in other clinical trials of anti-tumor drugs within 4 weeks before&#xD;
             enrollment;&#xD;
&#xD;
          8. Pregnant or lactating women;&#xD;
&#xD;
          9. The investigator judges other conditions that may affect the clinical study and the&#xD;
             outcome of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who did not follow the protocol.&#xD;
&#xD;
          2. The subject is aggravated or has a serious adverse reaction.&#xD;
&#xD;
          3. The subject himself requested to withdraw from the trial.&#xD;
&#xD;
          4. The patient is lost to follow-up or died.&#xD;
&#xD;
          5. The researcher believes that there is reason to withdraw&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the second affiliated hospital of Army medical university</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>40037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jianguo sun, Phd</last_name>
      <phone>023-68774490</phone>
      <email>sunjg09@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinqiao Hospital of Chongqing</investigator_affiliation>
    <investigator_full_name>Jianguo Sun</investigator_full_name>
    <investigator_title>Deputy director</investigator_title>
  </responsible_party>
  <keyword>nasopharynx cancer</keyword>
  <keyword>Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
  </condition_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/NCT03791944
org study id: XQonc-010
nct id: NCT03791944
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to
      existing domestic TPS.
The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing
      imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled.
      The primary endpoint of the study was the objective response rate (ORR), and the secondary
      endpoint was the local control rate and the incidence of treatment-related side effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Objective response rate
time frame: 3 months follow-up after treatment
description: Objective Remission Rate (ORR) is equal to complete remission (CR) + partial remission (PR)
measure: Local control rate
time frame: 3 months follow-up after treatment
description: Local control means that the tumor does not increase in imaging, but if the tumor does not increase, the patient with increased symptoms after treatment is not included in the local control range.
measure: incidence of treatment-related side effects
time frame: 3 months follow-up after treatment
description: Incidence of related side effects during disease treatment
arm group label: 3DV+TPS/VARIAN
arm group type: Experimental
description: Use 3DV+TPS to map targets and develop treatment plans. The intervention is 3DV+TPS and VARIAN.
arm group label: TPS/VARIAN
arm group type: Active Comparator
description: Use imported Varian TPS to map targets and develop treatment plans.
arm group label: 3DV+TPS/ Domestic accelerator
arm group type: Experimental
description: Use 3DV+TPS to map targets and develop treatment plans.
arm group label: TPS/ Domestic accelerator
arm group type: Active Comparator
description: Adopt domestic TPS hook target and develop treatment plan.
intervention type: Device
intervention name: 3DV+TPS/VARIAN
description: Use imported 3DV+TPS to map targets and develop treatment plans
arm group label: 3DV+TPS/VARIAN
intervention type: Device
intervention name: TPS / VARIAN
description: Use imported TPS to map targets and develop treatment plans
arm group label: TPS/VARIAN
intervention type: Device
intervention name: 3DV + TPS / Domestic Accelerator
description: Use domestic 3DV+TPS to delineate target areas and develop treatment plans
arm group label: 3DV+TPS/ Domestic accelerator
intervention type: Device
intervention name: TPS / Domestic Accelerator
description: Use domestic TPS to map targets and develop treatment plans
arm group label: TPS/ Domestic accelerator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinqiao Hospital of Chongqing
investigator full name: Jianguo Sun
investigator title: Deputy director
mesh term: Nasopharyngeal Carcinoma
mesh term: Nasopharyngeal Neoplasms