<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/NCT02237469</url>
  </required_header>
  <id_info>
    <org_study_id>HUG 13-184R</org_study_id>
    <nct_id>NCT02237469</nct_id>
  </id_info>
  <brief_title>Prone Breast Radiotherapy Treatment Planning Observational Study</brief_title>
  <acronym>HUGProne</acronym>
  <official_title>Retrospective Dosimetric Study of Prone Radiotherapy for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vincent Vinh-Hung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Varian Medical Systems</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study purpose is to evaluate whether or not clinical characteristics of women with breast&#xD;
      cancer can predict which position for radiation treatment, prone or supine, will be&#xD;
      associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation&#xD;
      dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed&#xD;
      dose to tumor bed and ipsilateral breast.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospectively identify women who received curative radiation treatment after breast&#xD;
      conserving cancer surgery, in whom simulation in prone and in supine position was performed.&#xD;
      Compare the treatment plans for doses to targets and to non-target organs, according to&#xD;
      clinical parameters of body mass index, size of breast, location of tumor and side.&#xD;
      Furthermore, evaluate whether a single CT slide is enough or not to predict a dosimetry&#xD;
      advantage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation dose to heart and lungs</measure>
    <time_frame>4 months</time_frame>
    <description>Computations of doses and verification of physics charts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation dose to tumor bed and ipsilateral breast</measure>
    <time_frame>4 months</time_frame>
    <description>Computations of doses and verification of physics charts.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Numbers of patients with dosimetry gain in prone position</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluate the dosimetry gain in subgroups classified according to body mass index, size of breast, side and location of tumor.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Prone and supine simulation</arm_group_label>
    <description>Women with breast cancer receiving simulation in prone and in supine position for adjuvant radiation treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Prone and supine simulation</intervention_name>
    <description>Treatment planning in the two positions.</description>
    <arm_group_label>Prone and supine simulation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients addressed for adjuvant radiation treatment after breast conserving&#xD;
        surgery for breast cancer, in whom simulation was done prone and supine.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast conserving surgery&#xD;
&#xD;
          -  Adjuvant radiation treatment&#xD;
&#xD;
          -  Simulation done prone and supine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Simulation in only one position&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Vinh-Hung, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Genova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Dipasquale G, Wang X, Chatelain-Fontanella V, Vinh-Hung V, Miralbell R. Automatic segmentation of breast in prone position: Correlation of similarity indexes and breast pendulousness with dose/volume parameters. Radiother Oncol. 2016 Jul;120(1):124-7. doi: 10.1016/j.radonc.2016.04.041. Epub 2016 May 10.</citation>
    <PMID>27178144</PMID>
  </reference>
  <reference>
    <citation>Andrianarison VA, Laouiti M, Fargier-Bochaton O, Dipasquale G, Wang X, Nguyen NP, Miralbell R, Vinh-Hung V. Contouring workload in adjuvant breast cancer radiotherapy. Cancer Radiother. 2018 Dec;22(8):747-753. doi: 10.1016/j.canrad.2018.01.008. Epub 2018 Oct 12.</citation>
    <PMID>30322819</PMID>
  </reference>
  <reference>
    <citation>Heymann S, Dipasquale G, Nguyen NP, San M, Gorobets O, Leduc N, Verellen D, Storme G, Van Parijs H, De Ridder M, Vinh-Hung V. Two-Level Factorial Pre-TomoBreast Pilot Study of Tomotherapy and Conventional Radiotherapy in Breast Cancer: Post Hoc Utility of a Mean Absolute Dose Deviation Penalty Score. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820947759. doi: 10.1177/1533033820947759.</citation>
    <PMID>32940569</PMID>
  </reference>
  <reference>
    <citation>Vinh-Hung V, Leduc N, Verellen D, Verschraegen C, Dipasquale G, Nguyen NP. The mean absolute dose deviation-A common metric for the evaluation of dose-volume histograms in radiation therapy. Med Dosim. 2020 Summer;45(2):186-189. doi: 10.1016/j.meddos.2019.10.004. Epub 2019 Nov 19.</citation>
    <PMID>31757715</PMID>
  </reference>
  <results_reference>
    <citation>Wang X, Fargier-Bochaton O, Dipasquale G, Laouiti M, Kountouri M, Gorobets O, Nguyen NP, Miralbell R, Vinh-Hung V. Is prone free breathing better than supine deep inspiration breath-hold for left whole-breast radiotherapy? A dosimetric analysis. Strahlenther Onkol. 2021 Apr;197(4):317-331. doi: 10.1007/s00066-020-01731-8. Epub 2021 Jan 8.</citation>
    <PMID>33416915</PMID>
  </results_reference>
  <results_reference>
    <citation>Fargier-Bochaton O, Wang X, Dipasquale G, Laouiti M, Kountouri M, Gorobets O, Nguyen NP, Miralbell R, Vinh-Hung V. Prone versus supine free-breathing for right-sided whole breast radiotherapy. Sci Rep. 2022 Jan 11;12(1):525. doi: 10.1038/s41598-021-04385-3.</citation>
    <PMID>35017568</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>December 18, 2022</last_update_submitted>
  <last_update_submitted_qc>December 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Vincent Vinh-Hung</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Breast conserving surgery.</keyword>
  <keyword>Radiotherapy.</keyword>
  <keyword>Treatment planning.</keyword>
  <keyword>Prone.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02237469
org study id: HUG 13-184R
nct id: NCT02237469
lead sponsor: 
collaborator: 
has dmc: No
The study purpose is to evaluate whether or not clinical characteristics of women with breast
      cancer can predict which position for radiation treatment, prone or supine, will be
      associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation
      dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed
      dose to tumor bed and ipsilateral breast.
Retrospectively identify women who received curative radiation treatment after breast
      conserving cancer surgery, in whom simulation in prone and in supine position was performed.
      Compare the treatment plans for doses to targets and to non-target organs, according to
      clinical parameters of body mass index, size of breast, location of tumor and side.
      Furthermore, evaluate whether a single CT slide is enough or not to predict a dosimetry
      advantage.
observational model: Case-Only
time perspective: Retrospective
measure: Radiation dose to heart and lungs
time frame: 4 months
description: Computations of doses and verification of physics charts.
measure: Radiation dose to tumor bed and ipsilateral breast
time frame: 4 months
description: Computations of doses and verification of physics charts.
measure: Numbers of patients with dosimetry gain in prone position
time frame: 2 years
description: Evaluate the dosimetry gain in subgroups classified according to body mass index, size of breast, side and location of tumor.
arm group label: Prone and supine simulation
description: Women with breast cancer receiving simulation in prone and in supine position for adjuvant radiation treatment.
intervention type: Radiation
intervention name: Prone and supine simulation
description: Treatment planning in the two positions.
arm group label: Prone and supine simulation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent Vinh-Hung, MD, PhD
role: Principal Investigator
affiliation: University of Genova
facility: 
country: Switzerland
citation: Dipasquale G, Wang X, Chatelain-Fontanella V, Vinh-Hung V, Miralbell R. Automatic segmentation of breast in prone position: Correlation of similarity indexes and breast pendulousness with dose/volume parameters. Radiother Oncol. 2016 Jul;120(1):124-7. doi: 10.1016/j.radonc.2016.04.041. Epub 2016 May 10.
PMID: 27178144
citation: Andrianarison VA, Laouiti M, Fargier-Bochaton O, Dipasquale G, Wang X, Nguyen NP, Miralbell R, Vinh-Hung V. Contouring workload in adjuvant breast cancer radiotherapy. Cancer Radiother. 2018 Dec;22(8):747-753. doi: 10.1016/j.canrad.2018.01.008. Epub 2018 Oct 12.
PMID: 30322819
citation: Heymann S, Dipasquale G, Nguyen NP, San M, Gorobets O, Leduc N, Verellen D, Storme G, Van Parijs H, De Ridder M, Vinh-Hung V. Two-Level Factorial Pre-TomoBreast Pilot Study of Tomotherapy and Conventional Radiotherapy in Breast Cancer: Post Hoc Utility of a Mean Absolute Dose Deviation Penalty Score. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820947759. doi: 10.1177/1533033820947759.
PMID: 32940569
citation: Vinh-Hung V, Leduc N, Verellen D, Verschraegen C, Dipasquale G, Nguyen NP. The mean absolute dose deviation-A common metric for the evaluation of dose-volume histograms in radiation therapy. Med Dosim. 2020 Summer;45(2):186-189. doi: 10.1016/j.meddos.2019.10.004. Epub 2019 Nov 19.
PMID: 31757715
citation: Wang X, Fargier-Bochaton O, Dipasquale G, Laouiti M, Kountouri M, Gorobets O, Nguyen NP, Miralbell R, Vinh-Hung V. Is prone free breathing better than supine deep inspiration breath-hold for left whole-breast radiotherapy? A dosimetric analysis. Strahlenther Onkol. 2021 Apr;197(4):317-331. doi: 10.1007/s00066-020-01731-8. Epub 2021 Jan 8.
PMID: 33416915
citation: Fargier-Bochaton O, Wang X, Dipasquale G, Laouiti M, Kountouri M, Gorobets O, Nguyen NP, Miralbell R, Vinh-Hung V. Prone versus supine free-breathing for right-sided whole breast radiotherapy. Sci Rep. 2022 Jan 11;12(1):525. doi: 10.1038/s41598-021-04385-3.
PMID: 35017568
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Vincent Vinh-Hung
investigator title: MD, PhD
mesh term: Breast Neoplasms