<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/NCT03017053</url>
  </required_header>
  <id_info>
    <org_study_id>15411950300</org_study_id>
    <nct_id>NCT03017053</nct_id>
  </id_info>
  <brief_title>The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor</brief_title>
  <official_title>The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate&#xD;
      management of the neck is therefore of paramount importance in the treatment of oral cancer.&#xD;
      However, there is still some controversy on the treatment of early maxillofacial&#xD;
      malignancies. Currently, investigators have no accurate uniform treatment standards,&#xD;
      including the National Comprehensive Cancer Network (NCCN) recommended between surgery and&#xD;
      radiotherapy options. Clinical evaluation indicated that lymph node-negative patients&#xD;
      eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with&#xD;
      true node-negative, preventive cervical lymph node dissection is obviously over-treatment,&#xD;
      and lower quality of life. Radiotherapy can avoid such surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor&#xD;
      pathologic factors.&#xD;
&#xD;
      This is a randomized, prospective, open, multicenter study. Intervention: Patients receive&#xD;
      primary tumor resection followed by radiotherapy.&#xD;
&#xD;
      Control: Patients receive primary tumor resection with selective neck dissection.&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      2 years neck control rates&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
      Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life&#xD;
&#xD;
      Endpoint definition:&#xD;
&#xD;
      1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion&#xD;
      from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear&#xD;
      evidence of recurrence or metastasis.&#xD;
&#xD;
      3 years, 5 years overall survival is defined as: the proportion of patients who survived from&#xD;
      the beginning of the study to the third and fifth year in the total enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck control rates</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Oral Cancer</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary surgery &amp; Radiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elective neck dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary surgery &amp; Elective neck dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Elective neck dissection</intervention_name>
    <description>Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor</description>
    <arm_group_label>Elective neck dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
          2. Age≥ 18 and≤ 75 years&#xD;
&#xD;
          3. Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx&#xD;
             Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area),&#xD;
             the depth of invasion &gt; 4mm in preoperative assessment&#xD;
&#xD;
          4. In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving&#xD;
             surgical resection&#xD;
&#xD;
          5. KPS≥ 70&#xD;
&#xD;
          6. Normal bone marrow reserve function and normal liver, kidney function&#xD;
&#xD;
          7. Expected survival period≥ 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to provide an informed consent&#xD;
&#xD;
          2. Evidence of oral distant metastasis or other malignancies&#xD;
&#xD;
          3. The patient has received prior surgery for primary tumor or lymph node ( except for&#xD;
             biopsy )&#xD;
&#xD;
          4. Prior radiotherapy for primary tumor&#xD;
&#xD;
          5. The patient has previously received anti-tumor biological targeted therapy&#xD;
&#xD;
          6. The patient has received chemotherapy or immunotherapy for primary tumors&#xD;
&#xD;
          7. Prior malignancy within the previous 5 years (except for cured skin basal cell&#xD;
             carcinoma or cervical carcinoma in situ)&#xD;
&#xD;
          8. With 3-4 grad Allergy to any drug in the treatment&#xD;
&#xD;
          9. Peripheral neuropathy&gt; 1 grade&#xD;
&#xD;
         10. Any unstable systematic disease (including active infection, uncontrolled high blood&#xD;
             pressure, unstable angina, onset of angina within the last 3 months, congestive heart&#xD;
             failure, myocardial infarction within the previous 12 months, severe arrhythmia&#xD;
             needing drug treatment, liver, kidney or metabolic disease)&#xD;
&#xD;
         11. HIV positive&#xD;
&#xD;
         12. Chronic diseases requiring immune agents or hormone therapy&#xD;
&#xD;
         13. Pregnant or lactating women&#xD;
&#xD;
         14. Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance&#xD;
             to the study&#xD;
&#xD;
         15. Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)&#xD;
&#xD;
         16. The patient has participated in other experimental therapy studies within 30 days&#xD;
&#xD;
         17. Researchers believe that the situation is unsuitable for participation in the group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chenping ZHANG, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Ninth People's Hospital Shanghai, China, 200011</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chenping ZHANG, Ph.D</last_name>
    <phone>+86-21-63136856</phone>
    <email>zhang.chenping@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chenping ZHANG, Ph.D</last_name>
      <phone>+86-21-63136856</phone>
      <email>zhang.chenping@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Chenping Zhang</investigator_full_name>
    <investigator_title>Principal Investigator,Head of Oral and Maxillofacial- Head and Neck Oncology</investigator_title>
  </responsible_party>
  <keyword>Neck dissection</keyword>
  <keyword>Survival</keyword>
  <keyword>Early oral cancer</keyword>
  <keyword>Early oral cavity squamous cancer with node negative neck</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
    <mesh_term>Lip Neoplasms</mesh_term>
  </condition_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/NCT03017053
org study id: 15411950300
nct id: NCT03017053
lead sponsor: 
has dmc: No
Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate
      management of the neck is therefore of paramount importance in the treatment of oral cancer.
      However, there is still some controversy on the treatment of early maxillofacial
      malignancies. Currently, investigators have no accurate uniform treatment standards,
      including the National Comprehensive Cancer Network (NCCN) recommended between surgery and
      radiotherapy options. Clinical evaluation indicated that lymph node-negative patients
      eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with
      true node-negative, preventive cervical lymph node dissection is obviously over-treatment,
      and lower quality of life. Radiotherapy can avoid such surgery.
Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor
      pathologic factors.

      This is a randomized, prospective, open, multicenter study. Intervention: Patients receive
      primary tumor resection followed by radiotherapy.

      Control: Patients receive primary tumor resection with selective neck dissection.

      Primary:

      2 years neck control rates

      Secondary:

      Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life

      Endpoint definition:

      1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion
      from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear
      evidence of recurrence or metastasis.

      3 years, 5 years overall survival is defined as: the proportion of patients who survived from
      the beginning of the study to the third and fifth year in the total enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neck control rates
time frame: 2 years
measure: Disease-free survival
time frame: 1 year
measure: Disease-free survival
time frame: 2 years
measure: Disease-free survival
time frame: 3 years
measure: Disease-free survival
time frame: 5 years
measure: Overall survival
time frame: 3 years
measure: Overall survival
time frame: 5 years
arm group label: Radiotherapy
arm group type: Experimental
description: Primary surgery & Radiotherapy
arm group label: Elective neck dissection
arm group type: Active Comparator
description: Primary surgery & Elective neck dissection
intervention type: Radiation
intervention name: Radiotherapy
description: Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
arm group label: Radiotherapy
intervention type: Procedure
intervention name: Elective neck dissection
description: Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
arm group label: Elective neck dissection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chenping ZHANG, Ph.D
role: Principal Investigator
affiliation: Shanghai Ninth People's Hospital Shanghai, China, 200011
last name: Chenping ZHANG, Ph.D
phone: +86-21-63136856
email: zhang.chenping@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Chenping Zhang
investigator title: Principal Investigator,Head of Oral and Maxillofacial- Head and Neck Oncology
mesh term: Mouth Neoplasms
mesh term: Lip Neoplasms
sharing ipd: No