<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/NCT02972177</url>
  </required_header>
  <id_info>
    <org_study_id>SHCHE201603</org_study_id>
    <nct_id>NCT02972177</nct_id>
  </id_info>
  <brief_title>Transbronchial Ablation for Peripheral Lung Tumor</brief_title>
  <official_title>Clinical Study of Navigation Bronchoscopy Guided Ablation for the Treatment of Peripheral Lung Tumor</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy&#xD;
      guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided&#xD;
      transbronchial ablation for treating inoperable malignant lung tumor. The study is designed&#xD;
      as a single-center prospective trial. The participating centers are Department of pulmonary&#xD;
      medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China.&#xD;
      Patients are divided into two groups, including radiofrequency ablation group and microwave&#xD;
      ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in&#xD;
      each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 7, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Local control rate</measure>
    <time_frame>Three months after ablation</time_frame>
    <description>Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From the time of treatment to the time of disease progression or death, assessed up to 1 year</time_frame>
    <description>PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival（OS）</measure>
    <time_frame>From the time of treatment to the time of the patient death, assessed up to 3 years</time_frame>
    <description>Overall survival（OS) is evaluated after the treatment of ablation until the patient death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific survival</measure>
    <time_frame>From the time of treatment to the time of the patient death, assessed up to 3 years</time_frame>
    <description>The cause of death is related to the patient's underlying malignancy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE 4.0</measure>
    <time_frame>From the time of treatment to the complication occured, assessed up to 1 month</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>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Radiofrequency ablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with inoperable peripheral lung tumor will be performed transbronchial radiofrequency ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microwave ablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with inoperable peripheral lung tumor will be performed transbronchial microwave ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency ablation</intervention_name>
    <description>Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.</description>
    <arm_group_label>Radiofrequency ablation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microwave ablation</intervention_name>
    <description>Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.</description>
    <arm_group_label>Microwave ablation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients older than 18 year-old.&#xD;
&#xD;
          2. Patients meeting one of the following criteria: 1) patients discovered with peripheral&#xD;
             lung lesions that have demonstrated to be lung cancer by pathology with the clinical&#xD;
             stage no later than IIA. 2) recurrent or progressive single lesion or solitary&#xD;
             intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other&#xD;
             treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and&#xD;
             no metastasis. 4) pulmonary metastases with effective treatment of primary disease,&#xD;
             the number of metastases no more than 5 and no other metastasis.&#xD;
&#xD;
          3. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than&#xD;
             50mm.&#xD;
&#xD;
          4. Patients are unsuitable for surgery assessed by multidisciplinary team and agree to&#xD;
             the primary treatment of ablation.&#xD;
&#xD;
          5. 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 or bronchoscopy shows that guided and treatment instruments cannot reach the&#xD;
             peripheral lung lesion.&#xD;
&#xD;
          4. There are large blood vessels or important structures adjacent to peripheral lung&#xD;
             lesion.&#xD;
&#xD;
          5. Researchers consider the patient do not fit for the study due to other reasons.&#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>86-021-22200000-1521</phone>
    <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>Jahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17.</citation>
    <PMID>23601905</PMID>
  </reference>
  <reference>
    <citation>Wasser EJ, Dupuy DE. Microwave ablation in the treatment of primary lung tumors. Semin Respir Crit Care Med. 2008 Aug;29(4):384-94. doi: 10.1055/s-2008-1081281.</citation>
    <PMID>18651356</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>Ye X, Fan W, Chen JH, Feng WJ, Gu SZ, Han Y, Huang GH, Lei GY, Li XG, Li YL, Li ZJ, Lin ZY, Liu BD, Liu Y, Peng ZM, Wang H, Yang WW, Yang X, Zhai B, Zhang J. Chinese expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors. Thorac Cancer. 2015 Jan;6(1):112-21. doi: 10.1111/1759-7714.12152. Epub 2015 Jan 7.</citation>
    <PMID>26273346</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 12, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</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, Department of Endoscopy</investigator_title>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>Transbronchial ablation</keyword>
  <keyword>Radiofrequency ablation</keyword>
  <keyword>Microwave ablation</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/NCT02972177
org study id: SHCHE201603
nct id: NCT02972177
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy
      guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.
The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided
      transbronchial ablation for treating inoperable malignant lung tumor. The study is designed
      as a single-center prospective trial. The participating centers are Department of pulmonary
      medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China.
      Patients are divided into two groups, including radiofrequency ablation group and microwave
      ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in
      each group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local control rate
time frame: Three months after ablation
description: Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.
measure: Progression-free survival (PFS)
time frame: From the time of treatment to the time of disease progression or death, assessed up to 1 year
description: PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.
measure: Overall survival（OS）
time frame: From the time of treatment to the time of the patient death, assessed up to 3 years
description: Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
measure: Cancer-specific survival
time frame: From the time of treatment to the time of the patient death, assessed up to 3 years
description: The cause of death is related to the patient's underlying malignancy.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE 4.0
time frame: From the time of treatment to the complication occured, assessed up to 1 month
description: Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.
arm group label: Radiofrequency ablation group
arm group type: Experimental
description: Patients with inoperable peripheral lung tumor will be performed transbronchial radiofrequency ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.
arm group label: Microwave ablation group
arm group type: Experimental
description: Patients with inoperable peripheral lung tumor will be performed transbronchial microwave ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.
intervention type: Procedure
intervention name: Radiofrequency ablation
description: Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.
arm group label: Radiofrequency ablation group
intervention type: Procedure
intervention name: Microwave ablation
description: Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.
arm group label: Microwave ablation 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: 86-021-22200000-1521
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: Jahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17.
PMID: 23601905
citation: Wasser EJ, Dupuy DE. Microwave ablation in the treatment of primary lung tumors. Semin Respir Crit Care Med. 2008 Aug;29(4):384-94. doi: 10.1055/s-2008-1081281.
PMID: 18651356
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: Ye X, Fan W, Chen JH, Feng WJ, Gu SZ, Han Y, Huang GH, Lei GY, Li XG, Li YL, Li ZJ, Lin ZY, Liu BD, Liu Y, Peng ZM, Wang H, Yang WW, Yang X, Zhai B, Zhang J. Chinese expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors. Thorac Cancer. 2015 Jan;6(1):112-21. doi: 10.1111/1759-7714.12152. Epub 2015 Jan 7.
PMID: 26273346
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Jiayuan Sun
investigator title: Director, Department of Endoscopy
mesh term: Lung Neoplasms
sharing ipd: No