xml: <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/NCT06020430</url>
    </required_header>
    <id_info>
      <org_study_id>OMCTV-HC-001</org_study_id>
      <nct_id>NCT06020430</nct_id>
    </id_info>
    <brief_title>Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy</brief_title>
    <official_title>Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hubei Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hubei Cancer 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>
        Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our&#xD;
        previous sturdy indicated that patients who received induction immunotherapy and subsequent&#xD;
        radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients&#xD;
        have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for&#xD;
        patients treated with immunotherapy and radiotherapy. According to retrospective and&#xD;
        prospective studies, omitting CTV radiation is feasible for patients undergoing concurrent&#xD;
        radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation&#xD;
        for patients responded to induction therapy with immunotherapy and chemotherapy will have&#xD;
        less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain&#xD;
        better immune function which will facilitate the immunotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 8, 2023</start_date>
    <completion_date type="Anticipated">October 8, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 8, 2025</primary_completion_date>
    <phase>N/A</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>grade 2 or more pneumonitis</measure>
      <time_frame>up to 6 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>local/regional control rate</measure>
      <time_frame>up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress free survival</measure>
      <time_frame>up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>grade 3 or more pneumonitis</measure>
      <time_frame>up to 6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>grade 3 or more esophagitis</measure>
      <time_frame>up to 6 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>Non Small Cell Lung Cancer</condition>
    <condition>Locally Advanced</condition>
    <condition>Radiotherapy</condition>
    <condition>Immunotherapy</condition>
    <arm_group>
      <arm_group_label>CTV-omitted</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CTV was omitted for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CTV-delineated</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>CTV was delineated for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>CTV omitted or delineated</intervention_name>
      <description>Patients who responded to the induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical radiotherapy group or CTV-delineated radiotherapy group.</description>
      <arm_group_label>CTV-delineated</arm_group_label>
      <arm_group_label>CTV-omitted</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Histologically or cytologically confirmed non-small cell lung cancer;&#xD;
  &#xD;
            2. stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging&#xD;
               system of the American Joint Committee on Cancer (AJCC) and Union for International&#xD;
               Cancer Control（UICC);&#xD;
  &#xD;
            3. inoperable or refuses surgery after induction therapy with immunotherapy and&#xD;
               chemoradiotherapy;&#xD;
  &#xD;
            4. After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy&#xD;
               was CR, PR or SD (with a decreasing trend);&#xD;
  &#xD;
            5. performance status 0-1;&#xD;
  &#xD;
            6. measurable or evaluable lesions;&#xD;
  &#xD;
            7. Survival expectancy is not less than 6 months;&#xD;
  &#xD;
            8. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. tumor progress after induction with immunothearoy and chemotherapy&#xD;
  &#xD;
            2. EGFR, ALK, or ROS1 mutation;&#xD;
  &#xD;
            3. Previous thoracic radiotherapy;&#xD;
  &#xD;
            4. grade 2 or more immune-related adverse events after induction immunotherapy&#xD;
  &#xD;
            5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in&#xD;
               situ);&#xD;
  &#xD;
            6. Pregnant or lactating women&#xD;
  &#xD;
            7. undergoing other clinical trials;&#xD;
  &#xD;
            8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe&#xD;
               cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;&#xD;
  &#xD;
            9. Patients with HIV positive and undergoing antiviral therapy;&#xD;
  &#xD;
           10. Active tuberculosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hubei Cancer Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430079</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Guang Han, PhD</last_name>
        <phone>+86 13886048178</phone>
        <email>hg7913@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hubei Cancer Hospital</investigator_affiliation>
      <investigator_full_name>HAN GUANG</investigator_full_name>
      <investigator_title>Director of the department of Radiotherapy Oncology</investigator_title>
    </responsible_party>
    <keyword>omitting CTV</keyword>
    <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>
  
  
text: 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/NCT06020430
  org study id: OMCTV-HC-001
  nct id: NCT06020430
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our
        previous sturdy indicated that patients who received induction immunotherapy and subsequent
        radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients
        have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for
        patients treated with immunotherapy and radiotherapy. According to retrospective and
        prospective studies, omitting CTV radiation is feasible for patients undergoing concurrent
        radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation
        for patients responded to induction therapy with immunotherapy and chemotherapy will have
        less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain
        better immune function which will facilitate the immunotherapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: grade 2 or more pneumonitis
  time frame: up to 6 months
  measure: local/regional control rate
  time frame: up to 12 months
  measure: Progress free survival
  time frame: up to 12 months
  measure: grade 3 or more pneumonitis
  time frame: up to 6 months
  measure: grade 3 or more esophagitis
  time frame: up to 6 months
  arm group label: CTV-omitted
  arm group type: Experimental
  description: CTV was omitted for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.
  arm group label: CTV-delineated
  arm group type: Active Comparator
  description: CTV was delineated for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.
  intervention type: Radiation
  intervention name: CTV omitted or delineated
  description: Patients who responded to the induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical radiotherapy group or CTV-delineated radiotherapy group.
  arm group label: CTV-delineated
  arm group label: CTV-omitted
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hubei Cancer Hospital
  investigator full name: HAN GUANG
  investigator title: Director of the department of Radiotherapy Oncology
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung