<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/NCT02262000</url>
  </required_header>
  <id_info>
    <org_study_id>WVU010513</org_study_id>
    <nct_id>NCT02262000</nct_id>
  </id_info>
  <brief_title>Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer</brief_title>
  <acronym>SABR</acronym>
  <official_title>A Phase II Clinical Trial of Image Guided Stereotactic Ablative Radiotherapy (SABR) for T2 and Microscopic T3 (PL3), N0,M0 Non-small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will help researchers learn about the best dose of radiation to be used when&#xD;
      treating large early stage non-small cell lung cancer (NSCLC) with a treatment called&#xD;
      stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC&#xD;
      show positive response. But, for large early stage NSCLC it may be better to give different&#xD;
      SABR doses than what is used in routine early stage NSCLC treatment. It is not understood&#xD;
      which dose is best for treating large early stage NSCLC. Therefore, this study can help&#xD;
      researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can&#xD;
      increase the chance of cure for large early stage NSCLC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment Plan:&#xD;
&#xD;
      7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular&#xD;
      intensity-modulated radiation therapy (IMRT).&#xD;
&#xD;
        -  Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations&#xD;
           where dose constraints for organs at risk can be EASILY met while optimal planning&#xD;
           target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule&#xD;
           is preferred.&#xD;
&#xD;
        -  All doses are prescribed to the tumor periphery.&#xD;
&#xD;
      For this protocol, patients will be followed only up to 2 years post radiation therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator left institution&#xD;
  </why_stopped>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">July 10, 2017</completion_date>
  <primary_completion_date type="Actual">July 7, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best Response</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>A - 7.5 Gy x 10 daily fractions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - 12 Gy x 5 daily fractions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Image Guided Stereotactic Ablative Radiotherapy</intervention_name>
    <arm_group_label>A - 7.5 Gy x 10 daily fractions</arm_group_label>
    <arm_group_label>B - 12 Gy x 5 daily fractions</arm_group_label>
    <other_name>SABR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-Small Cell Lung Cancer&#xD;
&#xD;
          -  T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm&#xD;
&#xD;
          -  Surgically inoperable&#xD;
&#xD;
          -  ECOG Performance 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pacemaker on the same side of the tumor&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Infection that requires IV antibiotics&#xD;
&#xD;
          -  Concomitant or adjuvant anti-neoplastic chemotherapy&#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>Malcolm Mattes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Hospitals Mary Babb Randolph Cancer Center</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>December 22, 2020</results_first_submitted>
  <results_first_submitted_qc>December 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2021</results_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non Small Cell Lung Cancer</keyword>
  <keyword>Surgically inoperable</keyword>
  <keyword>Radiation Therapy</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>A - 7.5 Gy x 10 Daily Fractions</title>
          <description>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT) at West Virginia University.&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
        </group>
        <group group_id="P2">
          <title>B - 12 Gy x 5 Daily Fractions</title>
          <description>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No participants from B - 12 Gy x 5 daily fractions were enrolled in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>A - 7.5 Gy x 10 Daily Fractions</title>
          <description>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
        </group>
        <group group_id="B2">
          <title>B - 12 Gy x 5 Daily Fractions</title>
          <description>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC</title>
        <time_frame>2 years</time_frame>
        <population>Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A - 7.5 Gy x 10 Daily Fractions</title>
            <description>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
          </group>
          <group group_id="O2">
            <title>B - 12 Gy x 5 Daily Fractions</title>
            <description>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC</title>
          <population>Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Response</title>
        <description>To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)</description>
        <time_frame>2 years</time_frame>
        <population>Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A - 7.5 Gy x 10 Daily Fractions</title>
            <description>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
          </group>
          <group group_id="O2">
            <title>B - 12 Gy x 5 Daily Fractions</title>
            <description>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Best Response</title>
          <description>To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)</description>
          <population>Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No adverse event data was available.</desc>
      <group_list>
        <group group_id="E1">
          <title>A - 7.5 Gy x 10 Daily Fractions</title>
          <description>Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
        </group>
        <group group_id="E2">
          <title>B - 12 Gy x 5 Daily Fractions</title>
          <description>Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved&#xD;
Image Guided Stereotactic Ablative Radiotherapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Compliance Coordinator</name_or_title>
      <organization>West Virginia Universtiy, WVCTSI</organization>
      <phone>304-293-0216</phone>
      <email>ctgovadmin@hsc.wvu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02262000
org study id: WVU010513
nct id: NCT02262000
lead sponsor: 
collaborator: 
has dmc: Yes
This study will help researchers learn about the best dose of radiation to be used when
      treating large early stage non-small cell lung cancer (NSCLC) with a treatment called
      stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC
      show positive response. But, for large early stage NSCLC it may be better to give different
      SABR doses than what is used in routine early stage NSCLC treatment. It is not understood
      which dose is best for treating large early stage NSCLC. Therefore, this study can help
      researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can
      increase the chance of cure for large early stage NSCLC.
Treatment Plan:

      7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular
      intensity-modulated radiation therapy (IMRT).

        -  Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations
           where dose constraints for organs at risk can be EASILY met while optimal planning
           target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule
           is preferred.

        -  All doses are prescribed to the tumor periphery.

      For this protocol, patients will be followed only up to 2 years post radiation therapy.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
time frame: 2 years
measure: Best Response
time frame: 2 years
description: To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
arm group label: A - 7.5 Gy x 10 daily fractions
arm group type: Experimental
description: Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
arm group label: B - 12 Gy x 5 daily fractions
arm group type: Experimental
description: Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved
intervention type: Radiation
intervention name: Image Guided Stereotactic Ablative Radiotherapy
arm group label: A - 7.5 Gy x 10 daily fractions
arm group label: B - 12 Gy x 5 daily fractions
other name: SABR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malcolm Mattes, MD
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 