<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/NCT02984033</url>
  </required_header>
  <id_info>
    <org_study_id>1642</org_study_id>
    <nct_id>NCT02984033</nct_id>
  </id_info>
  <brief_title>Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer</brief_title>
  <official_title>Quality of Life and Psychological Evaluation of Patients Affected by Head and Neck Cancer Treated With Curative Intent: Multicentric Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michele Tedeschi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prospective trial is to describe the quality of life and psychological effects in&#xD;
      patients with head and neck tumor receiving curative intent treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The multicentric prospective trial is to evaluate the quality of life and psychological&#xD;
      effects in patients with head and neck tumor treated by curative intent radiation therapy.&#xD;
      The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy&#xD;
      (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting&#xD;
      and 66-72 Gy in radical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patient enrolled&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Head and Neck patients</arm_group_label>
    <description>Patients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Head and Neck patients</intervention_name>
    <description>Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.</description>
    <arm_group_label>Head and Neck patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients affected by head and neck tumor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and&#xD;
             hypopharynx) in non-metastatic staging;&#xD;
&#xD;
          -  curative intent treatment (radiation therapy associated or not to chemotherapy;&#xD;
             surgery associated or not to post-operative radiotherapy and chemotherapy);&#xD;
&#xD;
          -  performance status &lt; 2;&#xD;
&#xD;
          -  age ≥ 18 years;&#xD;
&#xD;
          -  good knowledge of italian language;&#xD;
&#xD;
          -  written informed consent&#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>Ciro Franzese, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Humanitas Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Clinico Humanitas</investigator_affiliation>
    <investigator_full_name>Michele Tedeschi</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <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/NCT02984033
org study id: 1642
nct id: NCT02984033
lead sponsor: 
has dmc: Yes
The prospective trial is to describe the quality of life and psychological effects in
      patients with head and neck tumor receiving curative intent treatment
The multicentric prospective trial is to evaluate the quality of life and psychological
      effects in patients with head and neck tumor treated by curative intent radiation therapy.
      The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy
      (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting
      and 66-72 Gy in radical setting.
observational model: Cohort
time perspective: Prospective
measure: Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)
time frame: 18 months
arm group label: Head and Neck patients
description: Patients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis
intervention type: Radiation
intervention name: Head and Neck patients
description: Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.
arm group label: Head and Neck patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ciro Franzese, MD
role: Study Chair
affiliation: Humanitas Cancer Center
facility: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: Medical Doctor
mesh term: Head and Neck Neoplasms
sharing ipd: No