<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/NCT03029416</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-16-MULTI-21</org_study_id>
    <secondary_id>MCC-16-LUN-101</secondary_id>
    <nct_id>NCT03029416</nct_id>
  </id_info>
  <brief_title>Two Radiation Dose Schedules of SBRT to Lung Metastases &lt; 5cm in Dimension</brief_title>
  <official_title>A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases &lt; 5cm in Dimension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ronald McGarry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic&#xD;
      outcomes to 18Gy in three fractions (or dosing to a BED &lt;/-100Gy at the discretion of the&#xD;
      radiation oncologist) with respect to disease control and toxicity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using two different doses of SBRT, this study will examine the 6-month local disease control&#xD;
      rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in&#xD;
      pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will&#xD;
      develop a second trial to examine sequencing of immunotherapy with SBRT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PRMC Administrative Disapproval - Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">August 9, 2018</completion_date>
  <primary_completion_date type="Actual">July 20, 2018</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>30 Gy single fraction SBRT 18 Gy x three fractions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local Disease Control Rates</measure>
    <time_frame>6 MONTHS</time_frame>
    <description>Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Neoplasm Metastasis</condition>
  <condition>Cancer</condition>
  <condition>Radiation Therapy Complication</condition>
  <arm_group>
    <arm_group_label>Single Fraction of SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stereotactic Body Radiation Therapy delivered in a single session on one day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fractionated SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>Stereotactic Body Radiation Therapy using different fractionation schedules</description>
    <arm_group_label>Fractionated SBRT</arm_group_label>
    <arm_group_label>Single Fraction of SBRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to&#xD;
             lung.&#xD;
&#xD;
          -  Patients must not be eligible for therapy with curative intent (i.e. surgery,&#xD;
             radiation, etc).&#xD;
&#xD;
          -  Patients must have measurable disease, defined as at least one lesion that can be&#xD;
             accurately measured in at least one dimension&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  ECOG performance status &gt;/= 2 (Karnofsky≥60%)).&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with more than &gt;/=3 metastatic lung lesions or any one lesion greater than 5&#xD;
             cm. and/or extensive metastatic disease outside the chest.&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents.&#xD;
&#xD;
          -  Patients with active systemic, pulmonary, or pericardial infection.&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients with known brain metastases should be excluded from this clinical trial&#xD;
             because of their poor prognosis and because they often develop progressive neurologic&#xD;
             dysfunction that would confound the evaluation of neurologic and other adverse events.&#xD;
&#xD;
          -  Uncontrolled inter-current 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;
          -  Chemotherapy concurrent with SBRT is not allowed&#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>Ronald McGarry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Ronald McGarry</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>Neoplasm Metastasis</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/NCT03029416
org study id: MCC-16-MULTI-21
secondary id: MCC-16-LUN-101
nct id: NCT03029416
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic
      outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the
      radiation oncologist) with respect to disease control and toxicity.
Using two different doses of SBRT, this study will examine the 6-month local disease control
      rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in
      pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will
      develop a second trial to examine sequencing of immunotherapy with SBRT.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 30 Gy single fraction SBRT 18 Gy x three fractions
primary purpose: Treatment
masking: None (Open Label)
measure: Local Disease Control Rates
time frame: 6 MONTHS
description: Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1
arm group label: Single Fraction of SBRT
arm group type: Experimental
description: Stereotactic Body Radiation Therapy delivered in a single session on one day
arm group label: Fractionated SBRT
arm group type: Experimental
description: Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: Stereotactic Body Radiation Therapy using different fractionation schedules
arm group label: Fractionated SBRT
arm group label: Single Fraction of SBRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ronald McGarry, MD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Ronald McGarry
investigator title: Principal Investigator
mesh term: Neoplasm Metastasis
sharing ipd: No