<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/NCT03768856</url>
  </required_header>
  <id_info>
    <org_study_id>CASE4318</org_study_id>
    <nct_id>NCT03768856</nct_id>
  </id_info>
  <brief_title>Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma</brief_title>
  <official_title>Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</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>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the feasibility of using more advanced IMRT (intensity modulated&#xD;
      radiation therapy) techniques. This new technique is termed Temporally Feathered Radiation&#xD;
      Therapy (TFRT). TFRT is designed to reduce the side effects of conventional radiation&#xD;
      therapy. Research has shown that TFRT may lessen these side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine the feasibility of TFRT planning and&#xD;
      delivery for head and neck squamous cell carcinoma. Secondary objectives include estimating&#xD;
      grade 3-5 acute toxicity (within 90 days) and describing patient-reported outcomes (PRO) of&#xD;
      toxicity during and after TFRT. This study is planned as a single arm feasibility trial to&#xD;
      demonstrate clinical delivery of TFRT plans. Five patients will be accrued as a single&#xD;
      cohort.&#xD;
&#xD;
      When using standard-of-care intensity modulated radiation therapy (IMRT), a single radiation&#xD;
      plan is created and delivered on a daily basis Monday-Friday for a total of 7 weeks. In&#xD;
      contrast, when using TFRT, up to 5 different plans are created and delivered each specific&#xD;
      day of the week. Treatments will still occur on a daily basis Monday-Friday for 7 weeks. In&#xD;
      each of these radiation plans used for TFRT, the radiation dose that will be delivered to the&#xD;
      nearby healthy tissues will vary, allowing for increased time for normal tissue to recover&#xD;
      from radiation-induced damage. Once weekly, a slightly higher radiation dose will be&#xD;
      delivered to the &quot;feathered&quot; organ. On the remaining four days of the week, a slightly lower&#xD;
      radiation dose will be delivered to the &quot;feathered&quot; organ. The radiation dose that will be&#xD;
      delivered to the areas of cancer will not be changed. In this study, only the radiation dose&#xD;
      delivered to the normal healthy tissues will be changed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">December 3, 2019</completion_date>
  <primary_completion_date type="Actual">July 18, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation</measure>
    <time_frame>15 days from start of treatment</time_frame>
    <description>Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4</measure>
    <time_frame>Up to 90 days after treatment</time_frame>
    <description>Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire</measure>
    <time_frame>At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment</time_frame>
    <description>Global health status/health-related quality of life measurements based on European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-H&amp;N35). Scores range from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&amp;N35 Questionnaire</measure>
    <time_frame>At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment</time_frame>
    <description>Health-related quality of life measurements and symptoms among head and neck cancer participants based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire</measure>
    <time_frame>At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment</time_frame>
    <description>Xerostomia Questionnaire is a questionnaire used to describe mouth dryness and its effects on daily life. Scores range from 0-100. A high score represents a worse Xerostomia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Considered Compliant With Plan Delivery</measure>
    <time_frame>5 months from start of treatment</time_frame>
    <description>Number of participants who were able to complete the treatment course within the allotted time and without deviations and complete the questionnaires within the allotted time. Considered successful if 3/5 complete prescribed treatment course per protocol.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Temporally Feathered Radiation Therapy (TFRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Temporally Feathered Radiation Therapy (TFRT)</intervention_name>
    <description>Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
    <arm_group_label>Temporally Feathered Radiation Therapy (TFRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed squamous cell carcinoma&#xD;
             arising from a primary head and neck site (oral cavity, oropharynx,&#xD;
             larynx/hypopharynx, nasopharynx).TX-4, NX-3, MX-0 stages are permitted.&#xD;
&#xD;
          -  Subjects must be eligible for definitive radiation therapy (70Gy in 35 fractions) with&#xD;
             or without chemotherapy.&#xD;
&#xD;
          -  Karnofsky Performance status ≥80.&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects receiving any other investigational agents.&#xD;
&#xD;
          -  Postoperative radiotherapy is not permitted.&#xD;
&#xD;
          -  History of prior head and neck radiation therapy.&#xD;
&#xD;
          -  Subjects with uncontrolled inter-current illness including, but not limited to ongoing&#xD;
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,&#xD;
             cardiac arrhythmia, or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements.&#xD;
&#xD;
          -  Pregnant or breastfeeding women are excluded from this study because radiation therapy&#xD;
             has the potential for teratogenic or abortifacient effects. Because there is an&#xD;
             unknown, but potential risk for adverse events in nursing infants secondary to&#xD;
             treatment of the mother with radiation therapy, breastfeeding should be discontinued&#xD;
             if the mother is treated with radiation therapy. These potential risks may also apply&#xD;
             to other agents used in this study.&#xD;
&#xD;
          -  The patient cannot have distant metastatic disease (or M1 disease by AJCC 8th&#xD;
             edition).&#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>Nikhil Joshi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>July 13, 2020</results_first_submitted>
  <results_first_submitted_qc>July 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2020</results_first_posted>
  <last_update_submitted>June 1, 2022</last_update_submitted>
  <last_update_submitted_qc>June 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</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 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03768856/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03768856/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Temporally Feathered Radiation Therapy (TFRT)</title>
          <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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>
      <population>Participants enrolled in study</population>
      <group_list>
        <group group_id="B1">
          <title>Temporally Feathered Radiation Therapy (TFRT)</title>
          <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>50-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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>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="5"/>
                  </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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation</title>
        <description>Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.</description>
        <time_frame>15 days from start of treatment</time_frame>
        <population>Participants enrolled in study</population>
        <group_list>
          <group group_id="O1">
            <title>Temporally Feathered Radiation Therapy (TFRT)</title>
            <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation</title>
          <description>Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.</description>
          <population>Participants enrolled in study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4</title>
        <description>Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4</description>
        <time_frame>Up to 90 days after treatment</time_frame>
        <population>Participants enrolled in study</population>
        <group_list>
          <group group_id="O1">
            <title>Temporally Feathered Radiation Therapy (TFRT)</title>
            <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4</title>
          <description>Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4</description>
          <population>Participants enrolled in study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire</title>
        <description>Global health status/health-related quality of life measurements based on European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-H&amp;N35). Scores range from 0-100.</description>
        <time_frame>At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment</time_frame>
        <population>No participant were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error.</population>
        <group_list>
          <group group_id="O1">
            <title>Temporally Feathered Radiation Therapy (TFRT)</title>
            <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire</title>
          <description>Global health status/health-related quality of life measurements based on European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-H&amp;N35). Scores range from 0-100.</description>
          <population>No participant were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&amp;N35 Questionnaire</title>
        <description>Health-related quality of life measurements and symptoms among head and neck cancer participants based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.</description>
        <time_frame>At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment</time_frame>
        <population>No participants were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error.</population>
        <group_list>
          <group group_id="O1">
            <title>Temporally Feathered Radiation Therapy (TFRT)</title>
            <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&amp;N35 Questionnaire</title>
          <description>Health-related quality of life measurements and symptoms among head and neck cancer participants based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.</description>
          <population>No participants were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire</title>
        <description>Xerostomia Questionnaire is a questionnaire used to describe mouth dryness and its effects on daily life. Scores range from 0-100. A high score represents a worse Xerostomia.</description>
        <time_frame>At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment</time_frame>
        <population>No participants were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error.</population>
        <group_list>
          <group group_id="O1">
            <title>Temporally Feathered Radiation Therapy (TFRT)</title>
            <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire</title>
          <description>Xerostomia Questionnaire is a questionnaire used to describe mouth dryness and its effects on daily life. Scores range from 0-100. A high score represents a worse Xerostomia.</description>
          <population>No participants were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Considered Compliant With Plan Delivery</title>
        <description>Number of participants who were able to complete the treatment course within the allotted time and without deviations and complete the questionnaires within the allotted time. Considered successful if 3/5 complete prescribed treatment course per protocol.</description>
        <time_frame>5 months from start of treatment</time_frame>
        <population>Participants enrolled in study</population>
        <group_list>
          <group group_id="O1">
            <title>Temporally Feathered Radiation Therapy (TFRT)</title>
            <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Considered Compliant With Plan Delivery</title>
          <description>Number of participants who were able to complete the treatment course within the allotted time and without deviations and complete the questionnaires within the allotted time. Considered successful if 3/5 complete prescribed treatment course per protocol.</description>
          <population>Participants enrolled in study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 mos post post-treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Temporally Feathered Radiation Therapy (TFRT)</title>
          <description>Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term &quot;feathering&quot;.&#xD;
Temporally Feathered Radiation Therapy (TFRT): Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE v5.0</default_vocab>
        <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="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="5"/>
              </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="5"/>
              </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 Shlomo Koyfman</name_or_title>
      <organization>Cleveland Clinic, Case Comprehensive Cancer Center</organization>
      <phone>1-800-223-2273</phone>
      <email>TaussigResearch@ccf.org</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/NCT03768856
org study id: CASE4318
nct id: NCT03768856
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study will evaluate the feasibility of using more advanced IMRT (intensity modulated
      radiation therapy) techniques. This new technique is termed Temporally Feathered Radiation
      Therapy (TFRT). TFRT is designed to reduce the side effects of conventional radiation
      therapy. Research has shown that TFRT may lessen these side effects.
The primary objective of this study is to determine the feasibility of TFRT planning and
      delivery for head and neck squamous cell carcinoma. Secondary objectives include estimating
      grade 3-5 acute toxicity (within 90 days) and describing patient-reported outcomes (PRO) of
      toxicity during and after TFRT. This study is planned as a single arm feasibility trial to
      demonstrate clinical delivery of TFRT plans. Five patients will be accrued as a single
      cohort.

      When using standard-of-care intensity modulated radiation therapy (IMRT), a single radiation
      plan is created and delivered on a daily basis Monday-Friday for a total of 7 weeks. In
      contrast, when using TFRT, up to 5 different plans are created and delivered each specific
      day of the week. Treatments will still occur on a daily basis Monday-Friday for 7 weeks. In
      each of these radiation plans used for TFRT, the radiation dose that will be delivered to the
      nearby healthy tissues will vary, allowing for increased time for normal tissue to recover
      from radiation-induced damage. Once weekly, a slightly higher radiation dose will be
      delivered to the "feathered" organ. On the remaining four days of the week, a slightly lower
      radiation dose will be delivered to the "feathered" organ. The radiation dose that will be
      delivered to the areas of cancer will not be changed. In this study, only the radiation dose
      delivered to the normal healthy tissues will be changed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation
time frame: 15 days from start of treatment
description: Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.
measure: Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4
time frame: Up to 90 days after treatment
description: Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4
measure: Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire
time frame: At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment
description: Global health status/health-related quality of life measurements based on European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-H&N35). Scores range from 0-100.
measure: Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&N35 Questionnaire
time frame: At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment
description: Health-related quality of life measurements and symptoms among head and neck cancer participants based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.
measure: Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire
time frame: At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment
description: Xerostomia Questionnaire is a questionnaire used to describe mouth dryness and its effects on daily life. Scores range from 0-100. A high score represents a worse Xerostomia.
measure: Number of Participants Considered Compliant With Plan Delivery
time frame: 5 months from start of treatment
description: Number of participants who were able to complete the treatment course within the allotted time and without deviations and complete the questionnaires within the allotted time. Considered successful if 3/5 complete prescribed treatment course per protocol.
arm group label: Temporally Feathered Radiation Therapy (TFRT)
arm group type: Experimental
description: Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term "feathering".
intervention type: Radiation
intervention name: Temporally Feathered Radiation Therapy (TFRT)
description: Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.
arm group label: Temporally Feathered Radiation Therapy (TFRT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nikhil Joshi, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 