<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/NCT03804307</url>
  </required_header>
  <id_info>
    <org_study_id>RT 15-03 SHARON THORAX</org_study_id>
    <nct_id>NCT03804307</nct_id>
  </id_info>
  <brief_title>Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer</brief_title>
  <official_title>SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Thoracic Cancer: an Interventional, Randomized, Multicentric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study is to assess efficacy of a short course radiation treatment in patients with&#xD;
      symptomatic thoracic malignant lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard treatment for thoracic lesions (3000 cGy in 10 daily fractions of 300 cGy each) is&#xD;
      compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to&#xD;
      demonstrate non-inferiority of this scheme&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Anticipated">November 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 8, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale</measure>
    <time_frame>3 months</time_frame>
    <description>reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, coughing, dysphagia, dyspnea, brachial plexopathy, lymphedema)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acute toxicity in the two treatment groups</measure>
    <time_frame>3 months</time_frame>
    <description>incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late toxicity in the two treatment groups</measure>
    <time_frame>12 months</time_frame>
    <description>incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL</measure>
    <time_frame>12 months</time_frame>
    <description>changes in QoL after the treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Thoracic Cancer</condition>
  <condition>Radiotherapy</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients in this group are treated with 3000 cGy in 10 daily fraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>short course treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>standard treatment</intervention_name>
    <description>3000 cGy in 10 daily fractions</description>
    <arm_group_label>standard treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>short course treatment</intervention_name>
    <description>2000 cGy in 4 fractions administered twice a day</description>
    <arm_group_label>short course treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptomatic thoracic malignant lesions (primary solid tumors or metastases from solid&#xD;
             tumor)&#xD;
&#xD;
          -  age&gt; 18 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3&#xD;
&#xD;
          -  no changes in supportive care in the week before radiotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  previous irradiation of the same region&#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>Alessio G Morganti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, Unviersity of Bologna, S.Orsola-Malpighi Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alessio G Morganti, MD</last_name>
    <phone>0512143564</phone>
    <phone_ext>+39</phone_ext>
    <email>alessio.morganti2@unibo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessio G Morganti, MD</last_name>
      <phone>0512143564</phone>
      <phone_ext>+39</phone_ext>
      <email>alessio.morganti2@unibo.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Alessio Giuseppe Morganti</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Short Course Radiotherapy</keyword>
  <keyword>Symptomatic thoracic lesions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804307
org study id: RT 15-03 SHARON THORAX
nct id: NCT03804307
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to assess efficacy of a short course radiation treatment in patients with
      symptomatic thoracic malignant lesions
Standard treatment for thoracic lesions (3000 cGy in 10 daily fractions of 300 cGy each) is
      compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to
      demonstrate non-inferiority of this scheme
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
time frame: 3 months
description: reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, coughing, dysphagia, dyspnea, brachial plexopathy, lymphedema)
measure: acute toxicity in the two treatment groups
time frame: 3 months
description: incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)
measure: late toxicity in the two treatment groups
time frame: 12 months
description: incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbility Scoring Schema
measure: Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
time frame: 12 months
description: changes in QoL after the treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)
arm group label: standard treatment
arm group type: Active Comparator
description: patients in this group are treated with 3000 cGy in 10 daily fraction
arm group label: short course treatment
arm group type: Experimental
description: patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
intervention type: Radiation
intervention name: standard treatment
description: 3000 cGy in 10 daily fractions
arm group label: standard treatment
intervention type: Radiation
intervention name: short course treatment
description: 2000 cGy in 4 fractions administered twice a day
arm group label: short course treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessio G Morganti, MD
role: Principal Investigator
affiliation: Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, Unviersity of Bologna, S.Orsola-Malpighi Hospital
last name: Alessio G Morganti, MD
phone: 0512143564
phone ext: +39
email: alessio.morganti2@unibo.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Alessio Giuseppe Morganti
investigator title: Professor
mesh term: Thoracic Neoplasms
sharing ipd: No