<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/NCT03840408</url>
  </required_header>
  <id_info>
    <org_study_id>Shanghai</org_study_id>
    <nct_id>NCT03840408</nct_id>
  </id_info>
  <brief_title>Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer</brief_title>
  <official_title>Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 10th People's Hospital</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>
      Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung&#xD;
      cancer accounts for 85%. Only part of patients could be treated with radical surgery.&#xD;
      Mitochondria-targeted system therapy combined with radiofrequency ablation could be an&#xD;
      alternative treatment. Small sample clinical cases verified that this therapy could be an&#xD;
      efficacy and safe treatment in a short period. The primary aim of this trial is to determine&#xD;
      if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation&#xD;
      is comparable to that of standard surgical interventions for patients with non-small cell&#xD;
      lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>From the date of randomization until the date of first documented progression，assessed up to 60 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From the date of randomization until the date of death from any cause，assessed up to 60 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1753</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Mitochondrial therapy with radiofrequency ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation</intervention_name>
    <description>Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites</description>
    <arm_group_label>Mitochondrial therapy with radiofrequency ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Patients will be treated with surgery</description>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient can understand and voluntarily join the study, sign the informed consent&#xD;
             form, and the compliance is good.&#xD;
&#xD;
          -  Patients with single nodule.&#xD;
&#xD;
          -  Before IIB period according to the eighth edition of the TNM staging period.&#xD;
&#xD;
          -  No mediastinal lymph node metastasis.&#xD;
&#xD;
          -  No prior anticancer treatments including surgery, radiation,chemotherapy or local&#xD;
             treatments.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 0 to 1&#xD;
&#xD;
          -  Sufficient organ functions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bacterial or fungous infection.&#xD;
&#xD;
          -  Simultaneous or metachronous (within the past 5 years) double cancers.&#xD;
&#xD;
          -  Patients with contraindications to radiofrequency ablation and inability to complete&#xD;
             treatment;&#xD;
&#xD;
          -  Women during pregnancy or breast-feeding.&#xD;
&#xD;
          -  Uncontrollable diabetes mellitus.&#xD;
&#xD;
          -  Patients with severe heart, lung, kidney disease or other systemic diseases who have&#xD;
             been judged to have a severe impact on survival or who are pre-assessed to be unable&#xD;
             to tolerate thoracoscopic surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>LiH Fan, M.D.</last_name>
    <phone>+8613661599588</phone>
    <email>fanlih@aliyun.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ming Li, M.D.</last_name>
    <phone>+8613524348108</phone>
    <email>mlid163@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai 10th People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>+86200072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Li, M.D.</last_name>
      <phone>+8613524348108</phone>
      <email>mlid163@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Ming Li</investigator_full_name>
    <investigator_title>Associate senior doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT03840408
org study id: Shanghai
nct id: NCT03840408
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung
      cancer accounts for 85%. Only part of patients could be treated with radical surgery.
      Mitochondria-targeted system therapy combined with radiofrequency ablation could be an
      alternative treatment. Small sample clinical cases verified that this therapy could be an
      efficacy and safe treatment in a short period. The primary aim of this trial is to determine
      if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation
      is comparable to that of standard surgical interventions for patients with non-small cell
      lung cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: From the date of randomization until the date of first documented progression，assessed up to 60 months
measure: Overall survival
time frame: From the date of randomization until the date of death from any cause，assessed up to 60 months
arm group label: Mitochondrial therapy with radiofrequency ablation
arm group type: Experimental
arm group label: Surgery
arm group type: Active Comparator
intervention type: Other
intervention name: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation
description: Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites
arm group label: Mitochondrial therapy with radiofrequency ablation
intervention type: Procedure
intervention name: Surgery
description: Patients will be treated with surgery
arm group label: Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: LiH Fan, M.D.
phone: +8613661599588
email: fanlih@aliyun.com
last name: Ming Li, M.D.
phone: +8613524348108
email: mlid163@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Ming Li
investigator title: Associate senior doctor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung