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/NCT06008730</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00005105</org_study_id>
      <secondary_id>NCI-2023-02941</secondary_id>
      <secondary_id>STUDY00005105</secondary_id>
      <secondary_id>RAD5621-22</secondary_id>
      <secondary_id>P30CA138292</secondary_id>
      <nct_id>NCT06008730</nct_id>
    </id_info>
    <brief_title>Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer</brief_title>
    <official_title>Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial tests proton beam radiation therapy in patients with non-small cell lung&#xD;
        cancer who have undergone surgical resection and have lymph nodes involving the middle of the&#xD;
        chest. Proton therapy is a type of radiation treatment that kills cancer cells while avoiding&#xD;
        surrounding healthy tissue. Proton beam therapy is sometimes used after cancer surgery to&#xD;
        reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may&#xD;
        work better than conventional radiation treatment after surgery in patients with non-small&#xD;
        cell lung cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small&#xD;
        cell lung cancer (NSCLC).&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To measure the radiation dose to the circulating immune compartment and explore its&#xD;
        association with clinical endpoints.&#xD;
  &#xD;
        II. To assess the efficacy of PBRT for resected N2 NSCLC.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients undergo radiation treatment planning and then undergo proton beam radiation therapy&#xD;
        on study. Patients also undergo collection of blood samples.&#xD;
  &#xD;
        Patients are followed up for 24 months after first dose of radiotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>Phase 2</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>Incidence of adverse events (AEs)</measure>
      <time_frame>Up to 90 days from enrollment</time_frame>
      <description>AEs will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) and classified as either early (occurring any time from enrollment through 90 days) or late (occurring any time from 90 days through 2 years). Will also categorize toxicity according to grade and separately report toxicity of any grade and toxicity of high grade (grade 3 or greater). Descriptive statistics will be used to summarize the data.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radiation dose to immune compartment</measure>
      <time_frame>Single episode prior to first radiation treatment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>From date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation</time_frame>
      <description>Examine the association of dose with disease-free survival. Cox proportional hazard model along with Kalan-Meier method will be applied.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>From the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiation</time_frame>
      <description>Examine the association of dose with overall survival. Cox proportional hazard model along with Kaplan-Meier method will be applied.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Resectable Lung Non-Small Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Treatment (proton beam radiation therapy)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo collection of blood samples</description>
      <arm_group_label>Treatment (proton beam radiation therapy)</arm_group_label>
      <other_name>Biological Sample Collection</other_name>
      <other_name>Biospecimen Collected</other_name>
      <other_name>Specimen Collection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Proton Beam Radiation Therapy</intervention_name>
      <description>Undergo proton beam radiation therapy</description>
      <arm_group_label>Treatment (proton beam radiation therapy)</arm_group_label>
      <other_name>External beam radiation therapy protons (procedure)</other_name>
      <other_name>External Beam Radiotherapy (protons)</other_name>
      <other_name>PBRT</other_name>
      <other_name>Proton</other_name>
      <other_name>Proton EBRT</other_name>
      <other_name>Proton External Beam Radiotherapy</other_name>
      <other_name>Proton Radiation Therapy</other_name>
      <other_name>PROTON Therapy</other_name>
      <other_name>Radiation, Proton Beam</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Radiology, Treatment Planning</intervention_name>
      <description>Undergo radiation treatment planning</description>
      <arm_group_label>Treatment (proton beam radiation therapy)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;= 18 years&#xD;
  &#xD;
            -  Patients must have undergone complete surgical resection after pre-operative systemic&#xD;
               therapy. Complete resections are defined as BOTH lobectomy, sleeve lobectomy,&#xD;
               bilobectomy, or pneumonectomy AND lymph node dissection with at least three&#xD;
               mediastinal (N2) stations sampled&#xD;
  &#xD;
            -  Pathology report from surgical resection indicating complete resection of primary&#xD;
               tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node&#xD;
               (pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients&#xD;
               who have initially positive margins that are secondarily cleared on additional margins&#xD;
               will be eligible&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group Performance (ECOG) performance status =&lt; 2&#xD;
               (Karnofsky &gt;= 60%)&#xD;
  &#xD;
            -  Life expectancy &gt; 12 weeks as determined by the investigator&#xD;
  &#xD;
            -  Hemoglobin &gt;= 9.0 g/dl (no transfusions allowed within 7 days of simulation to meet&#xD;
               entry criteria) (within 28 days of cycle 1 day 1)&#xD;
  &#xD;
            -  White blood cell &gt;= 2000/uL (after at least 7 days without growth factor support or&#xD;
               transfusion) (within 28 days of cycle 1 day 1)&#xD;
  &#xD;
            -  Platelets &gt;= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to&#xD;
               meet entry criteria) (within 28 days of cycle 1 day 1)&#xD;
  &#xD;
            -  Serum creatinine =&lt; 2 mg/dL (or glomerular filtration rate &gt;= 40 mL/min) (within 28&#xD;
               days of cycle 1 day 1)&#xD;
  &#xD;
            -  Because radiotherapy is known to be teratogenic, female of child-bearing potential&#xD;
               (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy&#xD;
  &#xD;
            -  FCBP and men must agree to use adequate contraception (hormonal or barrier method of&#xD;
               birth control; abstinence) prior to study entry and for the duration of study&#xD;
               participation. Should a woman become pregnant or suspect she is pregnant while she or&#xD;
               her partner is participating in this study, she should inform her treating physician&#xD;
               immediately. Men treated or enrolled on this protocol must also agree to use adequate&#xD;
               contraception prior to the study, for the duration of study participation, and 3&#xD;
               months after completion of radiotherapy. A female of childbearing potential (FCBP) is&#xD;
               a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral&#xD;
               oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive&#xD;
               months (i.e., has had menses at any time in the preceding 24 consecutive months&#xD;
  &#xD;
            -  Completion of all previous therapy (including surgery, chemotherapy, or&#xD;
               investigational therapy) for the treatment of cancer &gt;= 2 weeks before the start of&#xD;
               radiotherapy&#xD;
  &#xD;
            -  Patients with known history or current symptoms of cardiac disease, or history of&#xD;
               treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac&#xD;
               function using the New York Heart Association Functional Classification. To be&#xD;
               eligible for this trial, patients should be class 2B or better&#xD;
  &#xD;
            -  Willingness and ability of the subject to comply with scheduled visits, drug&#xD;
               administration plan, protocol-specified laboratory tests, other study procedures, and&#xD;
               study restrictions&#xD;
  &#xD;
            -  Evidence of a personally signed informed consent indicating that the subject is aware&#xD;
               of the neoplastic nature of the disease and has been informed of the procedures to be&#xD;
               followed, the experimental nature of the therapy, alternatives, potential risks and&#xD;
               discomforts, potential benefits, and other pertinent aspects of study participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have stage IV disease&#xD;
  &#xD;
            -  Patients who have had systemic therapy less than 2 weeks prior to anticipated&#xD;
               radiotherapy start&#xD;
  &#xD;
            -  Patients who have received prior thoracic radiotherapy&#xD;
  &#xD;
            -  Patients who have a prior history of NSCLC (other than index diagnosis)&#xD;
  &#xD;
            -  Patients who have small cell lung cancer&#xD;
  &#xD;
            -  Patients whose tumors exhibit targetable alterations in EGFR or ALK&#xD;
  &#xD;
            -  Patients with incomplete surgical resection, including R1 (microscopic residual&#xD;
               disease) or R2 resection (macroscopic residual disease), sampling of fewer than three&#xD;
               mediastinal lymph node stations, unremoved positive lymph nodes, malignant pleural&#xD;
               effusion, or malignant pericardial effusion&#xD;
  &#xD;
            -  Patients who are receiving any other investigational agents or an investigational&#xD;
               device within 21 days before administration of first dose of study drugs&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
               infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
               arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements&#xD;
  &#xD;
            -  Significant cardiovascular disease (eg, myocardial infarction, arterial&#xD;
               thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of&#xD;
               study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New&#xD;
               York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled grade &gt;=&#xD;
               3 hypertension (diastolic blood pressure &gt;= 100 mmHg or systolic blood pressure &gt;= 160&#xD;
               mmHg) despite antihypertensive therapy&#xD;
  &#xD;
            -  The following vulnerable populations will not be offered participation in this study:&#xD;
  &#xD;
                 -  Adults with cognitive impairment or unable to consent&#xD;
  &#xD;
                 -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
  &#xD;
                 -  Pregnant women&#xD;
  &#xD;
                 -  Prisoners&#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>William Stokes</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University Hospital/Winship Cancer Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bill Stokes, MD</last_name>
      <phone>404-778-3473</phone>
      <email>william.stokes@emoryhealthcare.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Aparna H. Kesarwala, MD, PhD</last_name>
      <phone>404-778-3473</phone>
      <email>aparna.kesarwala@emory.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Emory University Hospital/Winship Cancer Institute</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tegan VandenBosch</last_name>
        <email>tegan.honor.vandenbosch@emory.edu</email>
      </contact>
      <investigator>
        <last_name>William Stokes, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Bill Stokes</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT06008730
  org study id: STUDY00005105
  secondary id: NCI-2023-02941
  secondary id: STUDY00005105
  secondary id: RAD5621-22
  secondary id: P30CA138292
  nct id: NCT06008730
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  This clinical trial tests proton beam radiation therapy in patients with non-small cell lung
        cancer who have undergone surgical resection and have lymph nodes involving the middle of the
        chest. Proton therapy is a type of radiation treatment that kills cancer cells while avoiding
        surrounding healthy tissue. Proton beam therapy is sometimes used after cancer surgery to
        reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may
        work better than conventional radiation treatment after surgery in patients with non-small
        cell lung cancer.
  PRIMARY OBJECTIVE:
  
        I. To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small
        cell lung cancer (NSCLC).
  
        SECONDARY OBJECTIVES:
  
        I. To measure the radiation dose to the circulating immune compartment and explore its
        association with clinical endpoints.
  
        II. To assess the efficacy of PBRT for resected N2 NSCLC.
  
        OUTLINE:
  
        Patients undergo radiation treatment planning and then undergo proton beam radiation therapy
        on study. Patients also undergo collection of blood samples.
  
        Patients are followed up for 24 months after first dose of radiotherapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of adverse events (AEs)
  time frame: Up to 90 days from enrollment
  description: AEs will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) and classified as either early (occurring any time from enrollment through 90 days) or late (occurring any time from 90 days through 2 years). Will also categorize toxicity according to grade and separately report toxicity of any grade and toxicity of high grade (grade 3 or greater). Descriptive statistics will be used to summarize the data.
  measure: Radiation dose to immune compartment
  time frame: Single episode prior to first radiation treatment
  measure: Disease-free survival
  time frame: From date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation
  description: Examine the association of dose with disease-free survival. Cox proportional hazard model along with Kalan-Meier method will be applied.
  measure: Overall survival
  time frame: From the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiation
  description: Examine the association of dose with overall survival. Cox proportional hazard model along with Kaplan-Meier method will be applied.
  arm group label: Treatment (proton beam radiation therapy)
  arm group type: Experimental
  description: Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study. Patients also undergo collection of blood samples.
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo collection of blood samples
  arm group label: Treatment (proton beam radiation therapy)
  other name: Biological Sample Collection
  other name: Biospecimen Collected
  other name: Specimen Collection
  intervention type: Radiation
  intervention name: Proton Beam Radiation Therapy
  description: Undergo proton beam radiation therapy
  arm group label: Treatment (proton beam radiation therapy)
  other name: External beam radiation therapy protons (procedure)
  other name: External Beam Radiotherapy (protons)
  other name: PBRT
  other name: Proton
  other name: Proton EBRT
  other name: Proton External Beam Radiotherapy
  other name: Proton Radiation Therapy
  other name: PROTON Therapy
  other name: Radiation, Proton Beam
  intervention type: Other
  intervention name: Radiology, Treatment Planning
  description: Undergo radiation treatment planning
  arm group label: Treatment (proton beam radiation therapy)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: William Stokes
  role: Principal Investigator
  affiliation: Emory University Hospital/Winship Cancer Institute
  last name: Bill Stokes, MD
  phone: 404-778-3473
  email: william.stokes@emoryhealthcare.org
  last name: Aparna H. Kesarwala, MD, PhD
  phone: 404-778-3473
  email: aparna.kesarwala@emory.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Bill Stokes
  investigator title: Principal Investigator
  mesh term: Carcinoma, Non-Small-Cell Lung