<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/NCT02970955</url>
  </required_header>
  <id_info>
    <org_study_id>1633</org_study_id>
    <nct_id>NCT02970955</nct_id>
  </id_info>
  <brief_title>Prospecitve Observational Study on a Risk Adaptive Scheme for SBRT for Thoracic Nodes Metastases</brief_title>
  <official_title>Prospective Observational Study on a Risk Adaptive Scheme for Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable Thoracic Nodes Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</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>
      Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except&#xD;
      for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body&#xD;
      radiation therapy (SBRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme&#xD;
      of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes&#xD;
      metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of&#xD;
      this technique is the ability to deliver a more selective irradiation to tumour's target&#xD;
      while reducing doses to normal tissue, optimizing the therapeutic window.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>Local control of disease</measure>
    <time_frame>7 years</time_frame>
    <description>Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival for patients</measure>
    <time_frame>7 years</time_frame>
    <description>A measure of the activity of the SBRT treatment on the disease by statistical methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival for patients</measure>
    <time_frame>7 years</time_frame>
    <description>Percentage of patients who are alive after a length of time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated by EORTC QLQ C30 questionnaires</measure>
    <time_frame>7 years</time_frame>
    <description>At the end of the treatment and during the first follow-up appointment patients will complete the EORTC QLQ C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematologic and non-hematologic toxicities</measure>
    <time_frame>7 years</time_frame>
    <description>Hematologic and non-hematologic toxicities will be graded according to Common Terminology Criteria for Adverse Events version 4.0</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Thoracic Nodes Metastases</condition>
  <arm_group>
    <arm_group_label>Inoperable thoracic nodes metastases</arm_group_label>
    <description>Oligometastatic patients with inoperable thoracic nodes metastases from any primary</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inoperable thoracic nodes metastases</intervention_name>
    <description>The radiation treatment will be delivered with three possible schedules, with a risk adaptive scheme according to number, site and size of metastatic nodes and based on the possibility to respect the constraints of healthy tissues</description>
    <arm_group_label>Inoperable thoracic nodes metastases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with inoperable thoracic nodes metastases from any primary, except for hematologic&#xD;
        malignancies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt;18 years with ECOG 0-2&#xD;
&#xD;
          -  Karnofsky index &gt; 70% (ECOG &gt;2)&#xD;
&#xD;
          -  Any primary, except for hematologic malignancies&#xD;
&#xD;
          -  DFI (Disease-free interval) from diagnosis &gt; 6 months&#xD;
&#xD;
          -  Unresectable lesions or inoperable patients or patients who refused surgery&#xD;
&#xD;
          -  Less than 3 metastatic thoracic nodes&#xD;
&#xD;
          -  No extrathoracic disease or other metastatic sites stable or responding after&#xD;
             chemotherapy, with less than 5 metastatic sites&#xD;
&#xD;
          -  No life threatening conditions&#xD;
&#xD;
          -  Chemotherapy completed at least 1 week before treatment&#xD;
&#xD;
          -  Chemotherapy started at least 1 week after treatment allowed&#xD;
&#xD;
          -  Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or&#xD;
             immunotherapy)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous RT in the same region&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with inability to 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>Davide Franceschini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Davide Franceschini</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20090</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>Neoplasm Metastasis</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/NCT02970955
org study id: 1633
nct id: NCT02970955
lead sponsor: 
has dmc: Yes
Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except
      for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body
      radiation therapy (SBRT).
The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme
      of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes
      metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of
      this technique is the ability to deliver a more selective irradiation to tumour's target
      while reducing doses to normal tissue, optimizing the therapeutic window.
observational model: Cohort
time perspective: Prospective
measure: Local control of disease
time frame: 7 years
description: Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients
measure: Progression-free survival for patients
time frame: 7 years
description: A measure of the activity of the SBRT treatment on the disease by statistical methods
measure: Overall survival for patients
time frame: 7 years
description: Percentage of patients who are alive after a length of time
measure: Quality of life evaluated by EORTC QLQ C30 questionnaires
time frame: 7 years
description: At the end of the treatment and during the first follow-up appointment patients will complete the EORTC QLQ C30
measure: Hematologic and non-hematologic toxicities
time frame: 7 years
description: Hematologic and non-hematologic toxicities will be graded according to Common Terminology Criteria for Adverse Events version 4.0
arm group label: Inoperable thoracic nodes metastases
description: Oligometastatic patients with inoperable thoracic nodes metastases from any primary
intervention type: Procedure
intervention name: Inoperable thoracic nodes metastases
description: The radiation treatment will be delivered with three possible schedules, with a risk adaptive scheme according to number, site and size of metastatic nodes and based on the possibility to respect the constraints of healthy tissues
arm group label: Inoperable thoracic nodes metastases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Davide Franceschini, MD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: Medical Doctor
mesh term: Neoplasm Metastasis
sharing ipd: No