<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/NCT03009630</url>
  </required_header>
  <id_info>
    <org_study_id>SHCHE201604</org_study_id>
    <nct_id>NCT03009630</nct_id>
  </id_info>
  <brief_title>ENB Guided RFA for Early-stage Peripheral Lung Cancer</brief_title>
  <official_title>The Clinical Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Radiofrequency Ablation (RFA) for the Treatment of Early-stage Peripheral Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Chest Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study was to evaluate the efficacy and safety of electromagnetic&#xD;
      navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of&#xD;
      early-stage peripheral lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of&#xD;
      patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a&#xD;
      single-center prospective trial with one arm. The participating centers are Department of&#xD;
      pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong&#xD;
      University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study.&#xD;
      Fifty patients are expected to be enrolled totally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>N/A</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>Objective response rate（ORR）of participants as assessed by the modified RECIST criteria</measure>
    <time_frame>Three months after ablation</time_frame>
    <description>Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) of participants</measure>
    <time_frame>From the time of treatment to the time of disease progression or death with a follow-up period of 3 years</time_frame>
    <description>Disease progression is evaluated by the variation of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival（OS）of participants</measure>
    <time_frame>From the time of treatment to the time of the patient death with a follow-up period of 5 years</time_frame>
    <description>Overall survival（OS) is evaluated after the treatment of ablation until the patient death.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>From the time of treatment to one month after operation</time_frame>
    <description>Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>RFA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with early-stage peripheral lung cancer will be performed RFA with the guidance of ENB. Post treatment response and follow up will be evaluated and carried out according to the standard procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA</intervention_name>
    <description>Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.</description>
    <arm_group_label>RFA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ENB</intervention_name>
    <description>ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.</description>
    <arm_group_label>RFA group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients discovered with peripheral lung nodules that have demonstrated to be&#xD;
             non-small cell lung cancer by pathology with the clinical stage of IA.&#xD;
&#xD;
          2. The tumors are solid or part-solid peripheral lung nodules and the length-diameter of&#xD;
             the nodules are more than 10 mm and no more than 30 mm.&#xD;
&#xD;
          3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to&#xD;
             the primary treatment of ablation.&#xD;
&#xD;
          4. Patients have good compliance and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and&#xD;
             other indications.&#xD;
&#xD;
          2. Patients have contraindications of general anesthesia.&#xD;
&#xD;
          3. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment&#xD;
             equipment to reach the peripheral lung lesion.&#xD;
&#xD;
          4. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation&#xD;
             leading to the guided and treatment equipment cannot reach the peripheral lung lesion.&#xD;
&#xD;
          5. There are large blood vessels or important structures adjacent to peripheral lung&#xD;
             lesion.&#xD;
&#xD;
          6. Researchers consider the patient do not fit for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiayuan Sun, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiayuan Sun, MD,PhD</last_name>
    <phone>86-021-22200000</phone>
    <phone_ext>1521</phone_ext>
    <email>jysun1976@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiayuan Sun, MD,PhD</last_name>
      <phone>18017321598</phone>
      <email>jysun1976@163.com</email>
    </contact>
    <investigator>
      <last_name>Jiayuan Sun, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.</citation>
    <PMID>27292045</PMID>
  </reference>
  <reference>
    <citation>Koizumi T, Tsushima K, Tanabe T, Agatsuma T, Yokoyama T, Ito M, Kanda S, Kobayashi T, Yasuo M. Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration. 2015;90(1):47-55. doi: 10.1159/000430825. Epub 2015 May 30.</citation>
    <PMID>26044954</PMID>
  </reference>
  <reference>
    <citation>Fernando HC, De Hoyos A, Landreneau RJ, Gilbert S, Gooding WE, Buenaventura PO, Christie NA, Belani C, Luketich JD. Radiofrequency ablation for the treatment of non-small cell lung cancer in marginal surgical candidates. J Thorac Cardiovasc Surg. 2005 Mar;129(3):639-44. doi: 10.1016/j.jtcvs.2004.10.019.</citation>
    <PMID>15746749</PMID>
  </reference>
  <reference>
    <citation>Dupuy DE, Fernando HC, Hillman S, Ng T, Tan AD, Sharma A, Rilling WS, Hong K, Putnam JB. Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer. 2015 Oct 1;121(19):3491-8. doi: 10.1002/cncr.29507. Epub 2015 Jun 19.</citation>
    <PMID>26096694</PMID>
  </reference>
  <reference>
    <citation>Anantham D, Feller-Kopman D, Shanmugham LN, Berman SM, DeCamp MM, Gangadharan SP, Eberhardt R, Herth F, Ernst A. Electromagnetic navigation bronchoscopy-guided fiducial placement for robotic stereotactic radiosurgery of lung tumors: a feasibility study. Chest. 2007 Sep;132(3):930-5. doi: 10.1378/chest.07-0522. Epub 2007 Jul 23.</citation>
    <PMID>17646225</PMID>
  </reference>
  <reference>
    <citation>Harms W, Krempien R, Grehn C, Hensley F, Debus J, Becker HD. Electromagnetically navigated brachytherapy as a new treatment option for peripheral pulmonary tumors. Strahlenther Onkol. 2006 Feb;182(2):108-11. doi: 10.1007/s00066-006-1503-2.</citation>
    <PMID>16447018</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Jiayuan Sun</investigator_full_name>
    <investigator_title>Director, Endoscopy Department</investigator_title>
  </responsible_party>
  <keyword>Electromagnetic navigation bronchoscopy(ENB)</keyword>
  <keyword>Radiofrequency ablation(RFA)</keyword>
  <keyword>Peripheral lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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/NCT03009630
org study id: SHCHE201604
nct id: NCT03009630
lead sponsor: 
has dmc: No
The objective of the study was to evaluate the efficacy and safety of electromagnetic
      navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of
      early-stage peripheral lung cancer.
The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of
      patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a
      single-center prospective trial with one arm. The participating centers are Department of
      pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong
      University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study.
      Fifty patients are expected to be enrolled totally.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate（ORR）of participants as assessed by the modified RECIST criteria
time frame: Three months after ablation
description: Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.
measure: Progression-free survival (PFS) of participants
time frame: From the time of treatment to the time of disease progression or death with a follow-up period of 3 years
description: Disease progression is evaluated by the variation of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria.
measure: Overall survival（OS）of participants
time frame: From the time of treatment to the time of the patient death with a follow-up period of 5 years
description: Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: From the time of treatment to one month after operation
description: Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.
arm group label: RFA group
arm group type: Experimental
description: Patients with early-stage peripheral lung cancer will be performed RFA with the guidance of ENB. Post treatment response and follow up will be evaluated and carried out according to the standard procedure.
intervention type: Procedure
intervention name: RFA
description: Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.
arm group label: RFA group
intervention type: Device
intervention name: ENB
description: ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.
arm group label: RFA group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiayuan Sun, MD,PhD
role: Principal Investigator
affiliation: Shanghai Chest Hospital
last name: Jiayuan Sun, MD,PhD
phone: 86-021-22200000
phone ext: 1521
email: jysun1976@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.
PMID: 27292045
citation: Koizumi T, Tsushima K, Tanabe T, Agatsuma T, Yokoyama T, Ito M, Kanda S, Kobayashi T, Yasuo M. Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration. 2015;90(1):47-55. doi: 10.1159/000430825. Epub 2015 May 30.
PMID: 26044954
citation: Fernando HC, De Hoyos A, Landreneau RJ, Gilbert S, Gooding WE, Buenaventura PO, Christie NA, Belani C, Luketich JD. Radiofrequency ablation for the treatment of non-small cell lung cancer in marginal surgical candidates. J Thorac Cardiovasc Surg. 2005 Mar;129(3):639-44. doi: 10.1016/j.jtcvs.2004.10.019.
PMID: 15746749
citation: Dupuy DE, Fernando HC, Hillman S, Ng T, Tan AD, Sharma A, Rilling WS, Hong K, Putnam JB. Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer. 2015 Oct 1;121(19):3491-8. doi: 10.1002/cncr.29507. Epub 2015 Jun 19.
PMID: 26096694
citation: Anantham D, Feller-Kopman D, Shanmugham LN, Berman SM, DeCamp MM, Gangadharan SP, Eberhardt R, Herth F, Ernst A. Electromagnetic navigation bronchoscopy-guided fiducial placement for robotic stereotactic radiosurgery of lung tumors: a feasibility study. Chest. 2007 Sep;132(3):930-5. doi: 10.1378/chest.07-0522. Epub 2007 Jul 23.
PMID: 17646225
citation: Harms W, Krempien R, Grehn C, Hensley F, Debus J, Becker HD. Electromagnetically navigated brachytherapy as a new treatment option for peripheral pulmonary tumors. Strahlenther Onkol. 2006 Feb;182(2):108-11. doi: 10.1007/s00066-006-1503-2.
PMID: 16447018
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Jiayuan Sun
investigator title: Director, Endoscopy Department
mesh term: Lung Neoplasms
sharing ipd: No