<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/NCT03008694</url>
  </required_header>
  <id_info>
    <org_study_id>ZhongnanH</org_study_id>
    <nct_id>NCT03008694</nct_id>
  </id_info>
  <brief_title>Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients</brief_title>
  <official_title>Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongnan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongnan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning&#xD;
      in oral Cancer patients. Progress-free survival (PFS) will be compared with historical&#xD;
      control as defined in the protocol&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiotherapy improves local control and overall survival for oral cavity cancer patients&#xD;
      after surgery. However, limited locoregional control remains a key issue in the management of&#xD;
      oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of&#xD;
      oral cavity cancer. The purpose of this study is to determine the locoregional control in&#xD;
      PET/CT based radiotherapy treatment planning in the treatment of oral cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>progress free survival</measure>
    <time_frame>baseline to 2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Oral Cancer</condition>
  <condition>Radiotherapy; Complications</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/CT</intervention_name>
    <description>pet/ct is used as radiotherapy simulation</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed oral squamous-cell carcinoma&#xD;
&#xD;
          -  Age &gt; 17 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  ECOG Performance status 0-2&#xD;
&#xD;
          -  Must be able to start RT within 4 weeks after PET/CT simulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  stage IV disease diagnosed before acquisition of staging PET/CT&#xD;
&#xD;
          -  prior radiotherapy to oral and neck&#xD;
&#xD;
          -  Unable to understand study participation&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  pregnant or breast feeding mothers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongnan Hospital</investigator_affiliation>
    <investigator_full_name>yahua zhong</investigator_full_name>
    <investigator_title>Director,oncology , Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03008694
org study id: ZhongnanH
nct id: NCT03008694
lead sponsor: 
has dmc: No
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning
      in oral Cancer patients. Progress-free survival (PFS) will be compared with historical
      control as defined in the protocol
Radiotherapy improves local control and overall survival for oral cavity cancer patients
      after surgery. However, limited locoregional control remains a key issue in the management of
      oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of
      oral cavity cancer. The purpose of this study is to determine the locoregional control in
      PET/CT based radiotherapy treatment planning in the treatment of oral cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progress free survival
time frame: baseline to 2 years
arm group label: 1
arm group type: Experimental
description: PET/CT
intervention type: Device
intervention name: PET/CT
description: pet/ct is used as radiotherapy simulation
arm group label: 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Zhongnan Hospital
investigator full name: yahua zhong
investigator title: Director,oncology , Principal Investigator, Clinical Professor
mesh term: Mouth Neoplasms
sharing ipd: Undecided