<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/NCT02224547</url>
  </required_header>
  <id_info>
    <org_study_id>Lung Vero SBRT</org_study_id>
    <nct_id>NCT02224547</nct_id>
  </id_info>
  <brief_title>Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System</brief_title>
  <official_title>Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to perform prospective data analysis on tumor response in terms&#xD;
      of local tumor control after 2 years, potential acute and late toxicity and survival in&#xD;
      patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are&#xD;
      medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens&#xD;
      used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a&#xD;
      risk-adapted approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Anticipated">December 2017</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>Toxicity of grade 3+ as assessed by NCI CTCAE v4.0</measure>
    <time_frame>From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity</time_frame>
    <description>To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to local progression</measure>
    <time_frame>every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months.</time_frame>
    <description>Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT</time_frame>
    <description>Quality of life</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Non-Small Cell Lung Carcinoma</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy (Fractionated stereotactic body radiation)</intervention_name>
    <description>Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.</description>
    <arm_group_label>Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology&#xD;
&#xD;
          2. Maximal tumor diameter of 6 cm&#xD;
&#xD;
          3. Only T3 lesions based upon thoracic wall involvement, only 1 lesion&#xD;
&#xD;
          4. Informed consent is required&#xD;
&#xD;
          5. Life expectancy of at least 6 months&#xD;
&#xD;
          6. Age &gt;/= 18 y.&#xD;
&#xD;
          7. Karnofsky score ≥ 70 or ECOG score ≤ 2&#xD;
&#xD;
          8. Inoperable patients or patients refusing surgery&#xD;
&#xD;
          9. Patients with measurable lesion (according to RECIST criteria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of small cell lung cancer&#xD;
&#xD;
          2. Lymph node involvement&#xD;
&#xD;
          3. Prior radiotherapy to the chest and/or mediastinum&#xD;
&#xD;
          4. No chemotherapy and/or targeted treatment within 3 months before SBRT&#xD;
&#xD;
          5. Pregnant or lactating women&#xD;
&#xD;
          6. Known allergy for CT contrast&#xD;
&#xD;
          7. No FDG-PET&#xD;
&#xD;
          8. Mental condition rendering the patient unable to understand the nature, scope, and&#xD;
             possible consequences of the study.&#xD;
&#xD;
          9. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to&#xD;
             return for follow-up visits, extreme degradation of lung function tests and patients&#xD;
             not likely to complete the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Collen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Brussel Radiotherapie dienst</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine Collen, MD</last_name>
    <phone>+324763438</phone>
    <email>christine.collen@uzbrussel.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Harijati Versmessen, MD</last_name>
    <phone>+324763407</phone>
    <email>harijati.versmessen@uzbrussel.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Brussel Radiotherapie dienst</name>
      <address>
        <city>Jette</city>
        <state>Brussels</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Collen, MD</last_name>
      <phone>+3224763438</phone>
      <email>christine.collen@uzbrussel.be</email>
    </contact>
    <contact_backup>
      <last_name>Harijati Versmessen, MD</last_name>
      <phone>+3224763407</phone>
      <email>harijati.versmessen@uzbrussel.be</email>
    </contact_backup>
    <investigator>
      <last_name>Christine Collen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>May 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Christine Collen, MD.</investigator_full_name>
    <investigator_title>Radiaton Oncologist</investigator_title>
  </responsible_party>
  <keyword>non-small cell lung cancer</keyword>
  <keyword>lung carcinoma</keyword>
  <keyword>NSCLC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <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>


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/NCT02224547
org study id: Lung Vero SBRT
nct id: NCT02224547
lead sponsor: 
has dmc: Yes
The purpose of this study is to perform prospective data analysis on tumor response in terms
      of local tumor control after 2 years, potential acute and late toxicity and survival in
      patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are
      medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens
      used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a
      risk-adapted approach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicity of grade 3+ as assessed by NCI CTCAE v4.0
time frame: From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity
description: To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT)
measure: Time to local progression
time frame: every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months.
description: Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence.
measure: Quality of life
time frame: baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT
description: Quality of life
arm group label: Radiotherapy
arm group type: Experimental
description: For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.
intervention type: Radiation
intervention name: Radiotherapy (Fractionated stereotactic body radiation)
description: Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.
arm group label: Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Christine Collen, MD
role: Principal Investigator
affiliation: UZ Brussel Radiotherapie dienst
last name: Christine Collen, MD
phone: +324763438
email: christine.collen@uzbrussel.be
last name: Harijati Versmessen, MD
phone: +324763407
email: harijati.versmessen@uzbrussel.be
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Christine Collen, MD.
investigator title: Radiaton Oncologist
mesh term: Carcinoma
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung