<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/NCT03804073</url>
  </required_header>
  <id_info>
    <org_study_id>RT 15-05 SHARON HEAD AND NECK</org_study_id>
    <nct_id>NCT03804073</nct_id>
  </id_info>
  <brief_title>Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer</brief_title>
  <official_title>SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck 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 head and neck (H&amp;N) malignant lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard treatment for H&amp;N 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</measure>
    <time_frame>3 months</time_frame>
    <description>reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment</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 Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria</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</measure>
    <time_frame>12 months</time_frame>
    <description>changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Head and Neck 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 H&amp;N 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, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity 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 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 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 head and neck lesions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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/NCT03804073
org study id: RT 15-05 SHARON HEAD AND NECK
nct id: NCT03804073
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 head and neck (H&N) malignant lesions
Standard treatment for H&N 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
time frame: 3 months
description: reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
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 Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria
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
time frame: 12 months
description: changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL)
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, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity 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: Head and Neck Neoplasms
sharing ipd: No