<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/NCT02204761</url>
  </required_header>
  <id_info>
    <org_study_id>9148</org_study_id>
    <secondary_id>NCI-2014-01468</secondary_id>
    <secondary_id>9148</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT02204761</nct_id>
  </id_info>
  <brief_title>Proton Beam Re-Irradiation in Thoracic Cancers</brief_title>
  <official_title>Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies proton beam radiation therapy in treating patients with&#xD;
      thoracic cancer that has come back and have received prior radiation therapy. Proton beam&#xD;
      radiation therapy uses high energy protons to kill tumor cells and may cause less damage to&#xD;
      normal tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton&#xD;
      therapy, with prospectively applied normal organ radiation dose limits.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the efficacy of thoracic re-irradiation with proton therapy.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo proton beam radiation therapy per standard of care.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2014</start_date>
  <completion_date type="Actual">September 7, 2017</completion_date>
  <primary_completion_date type="Actual">September 7, 2017</primary_completion_date>
  <phase>N/A</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>Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment</measure>
    <time_frame>Up to 3 months post-treatment</time_frame>
    <description>Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment</measure>
    <time_frame>Up to 3 months post-treatment</time_frame>
    <description>Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Local Control of Cancer</measure>
    <time_frame>Up to 3 months post-treatment</time_frame>
    <description>Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Alive</measure>
    <time_frame>Up to 3 months post-treatment</time_frame>
    <description>Number of participants alive.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Metastatic Malignant Neoplasm in the Lung</condition>
  <condition>Recurrent Disease</condition>
  <condition>Thoracic Neoplasm</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proton beam radiation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Proton Beam Radiation Therapy</intervention_name>
    <description>Undergo proton beam re-irradiation therapy</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of child-bearing age must have a negative pregnancy test&#xD;
&#xD;
          -  Patients must have received prior radiation treatment to the chest; records of prior&#xD;
             radiation treatment must be available&#xD;
&#xD;
          -  Patients must have received prior chest radiation at least 3 months prior to&#xD;
             enrollment in this trial; radiation treatment to other body sites not overlapping with&#xD;
             current radiation fields are allowed within the 3 months period (example, brain&#xD;
             radiation is allowed)&#xD;
&#xD;
          -  Patients must have a prior diagnosis of cancer inside the thoracic cavity; both&#xD;
             primary thoracic malignancies (such as lung cancer) as well as metastatic lesions&#xD;
             (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed;&#xD;
             patient must have pathologic confirmation of the recurrent thoracic tumor, or have an&#xD;
             enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6&#xD;
             weeks apart, with either a &gt; 25% or &gt; 5 mm increase in longest dimension)&#xD;
&#xD;
          -  Patients must have a life expectancy of &gt; 6 months&#xD;
&#xD;
          -  Patients must have measurable disease to be treated with proton radiation (minimum&#xD;
             tumor dimension at least 10 mm on CT imaging)&#xD;
&#xD;
          -  Patients should have either non-metastatic cancer of the thorax, or metastatic cancer&#xD;
             to the thorax and candidate for definitive radiation dose to the thoracic tumor (not&#xD;
             palliative intent), tumor radiation dose to at least BED2Gy 60 Gy&#xD;
&#xD;
          -  Patients must be able to receive proton radiation treatment&#xD;
&#xD;
          -  All stages of cancer are eligible&#xD;
&#xD;
          -  There are no limits on prior therapy; patients are allowed to have prior chemotherapy&#xD;
             and surgery; patients are allowed to have concurrent chemotherapy with radiation&#xD;
             treatment; patients are allowed to have chemotherapy or surgery after radiation&#xD;
             treatment&#xD;
&#xD;
          -  Patients are allowed to be on another study concurrent with this protocol&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have never received radiation to the chest&#xD;
&#xD;
          -  Patients who received radiation to the chest within the past 3 months (in a region&#xD;
             that overlaps with current radiation fields)&#xD;
&#xD;
          -  Patients with life expectancy &lt; 6 months&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients unable to provide informed consent&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jing Zeng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProCure Proton Therapy Center-Seattle</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>September 5, 2018</results_first_submitted>
  <results_first_submitted_qc>November 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 20, 2018</results_first_posted>
  <last_update_submitted>November 18, 2018</last_update_submitted>
  <last_update_submitted_qc>November 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Jing Zeng</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>Neoplasms</mesh_term>
    <mesh_term>Thoracic Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 21, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02204761/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Proton Beam Radiation Therapy)</title>
          <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Proton Beam Radiation Therapy)</title>
          <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.7" spread="8.8"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants with Grade 3+ toxicity from radiation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment</title>
        <description>Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.</description>
        <time_frame>Up to 3 months post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Proton Beam Radiation Therapy)</title>
            <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment</title>
          <description>Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment</title>
        <description>Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.</description>
        <time_frame>Up to 3 months post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Proton Beam Radiation Therapy)</title>
            <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment</title>
          <description>Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Local Control of Cancer</title>
        <description>Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.</description>
        <time_frame>Up to 3 months post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Proton Beam Radiation Therapy)</title>
            <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Local Control of Cancer</title>
          <description>Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Alive</title>
        <description>Number of participants alive.</description>
        <time_frame>Up to 3 months post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Proton Beam Radiation Therapy)</title>
            <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Alive</title>
          <description>Number of participants alive.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Proton Beam Radiation Therapy)</title>
          <description>Patients undergo proton beam radiation therapy per standard of care.&#xD;
Proton Beam Radiation Therapy: Undergo proton beam radiation therapy</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </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="6"/>
              </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>Dr. Jing Zeng</name_or_title>
      <organization>University of Washington Medical Center</organization>
      <phone>2065984110</phone>
      <email>jzeng13@uw.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/NCT02204761
org study id: 9148
secondary id: NCI-2014-01468
secondary id: 9148
secondary id: P30CA015704
nct id: NCT02204761
lead sponsor: 
collaborator: 
has dmc: No
This pilot clinical trial studies proton beam radiation therapy in treating patients with
      thoracic cancer that has come back and have received prior radiation therapy. Proton beam
      radiation therapy uses high energy protons to kill tumor cells and may cause less damage to
      normal tissue.
PRIMARY OBJECTIVES:

      I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton
      therapy, with prospectively applied normal organ radiation dose limits.

      SECONDARY OBJECTIVES:

      I. To assess the efficacy of thoracic re-irradiation with proton therapy.

      OUTLINE:

      Patients undergo proton beam radiation therapy per standard of care.

      After completion of study treatment, patients are followed up at 3 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
time frame: Up to 3 months post-treatment
description: Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.
measure: Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment
time frame: Up to 3 months post-treatment
description: Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.
measure: Number of Participants With Local Control of Cancer
time frame: Up to 3 months post-treatment
description: Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.
measure: Number of Participants Alive
time frame: Up to 3 months post-treatment
description: Number of participants alive.
arm group label: Treatment
arm group type: Experimental
description: Proton beam radiation therapy
intervention type: Radiation
intervention name: Proton Beam Radiation Therapy
description: Undergo proton beam re-irradiation therapy
arm group label: Treatment
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jing Zeng
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Jing Zeng
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Thoracic Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 