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/NCT06037733</url>
    </required_header>
    <id_info>
      <org_study_id>OMCTV-HC-002</org_study_id>
      <nct_id>NCT06037733</nct_id>
    </id_info>
    <brief_title>Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy</brief_title>
    <official_title>Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy</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>
      <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 aim of this randomized study is to investigate pneumonitis, local tumor control, and&#xD;
        survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC&#xD;
        responded to immunotherapy and chemotherapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can&#xD;
        improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that&#xD;
        patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of&#xD;
        pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged&#xD;
        to optimize the radiotherapy dose and target volume for patients treated with immunotherapy&#xD;
        and radiotherapy. According to retrospective and prospective studies, omitting primary tumor&#xD;
        CTV radiation therapy showed no reduction in local control and survival for locally advanced&#xD;
        NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with&#xD;
        immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local&#xD;
        control rate. Omitting CTV may also retain better immune function which will facilitate the&#xD;
        immunotherapy.&#xD;
      </textblock>
    </detailed_description>
    <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>Prevention</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>Advanced Non-Small Cell Squamous Lung Cancer</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 primary tumor radiotherapy for advanced NSCLC who responded to 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 primary tumor radiotherapy for 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 therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted 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 advanced non-small cell lung cancer&#xD;
               (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);&#xD;
  &#xD;
            2. After over two cycles of chemotherapy combined with immunotherapy, the efficacy was&#xD;
               CR, PR or SD (with a decreasing trend);&#xD;
  &#xD;
            3. Age 18 to 80 years old, performance status 0-1;&#xD;
  &#xD;
            4. measurable or evaluable lesions;&#xD;
  &#xD;
            5. Survival expectancy is not less than 6 months;&#xD;
  &#xD;
            6. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. tumor progress after therapy with immunotherapy 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>
    <overall_official>
      <last_name>Guang Han, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guang Han, PhD</last_name>
      <phone>+86 13886048178</phone>
      <email>hg7913@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hubei Cancer Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430079</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>
    </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/NCT06037733
  org study id: OMCTV-HC-002
  nct id: NCT06037733
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this randomized study is to investigate pneumonitis, local tumor control, and
        survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC
        responded to immunotherapy and chemotherapy
  Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can
        improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that
        patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of
        pneumonitis. Patients suffered grade 2 or more pneumonitis 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 primary tumor
        CTV radiation therapy showed no reduction in local control and survival for locally advanced
        NSCLC. It is postulated that omitting CTV radiation for patients responded to 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: Prevention
  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 primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy.
  arm group label: CTV-delineated
  arm group type: Active Comparator
  description: CTV was delineated for primary tumor radiotherapy for 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 therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted 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
  last name: Guang Han, PhD
  role: Principal Investigator
  affiliation: Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
  last name: Guang Han, PhD
  phone: +86 13886048178
  email: hg7913@hotmail.com
  facility: 
  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