<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/NCT02231112</url>
  </required_header>
  <id_info>
    <org_study_id>2014-06-138-001</org_study_id>
    <nct_id>NCT02231112</nct_id>
  </id_info>
  <brief_title>Whole Breast RT on Prone Position in Korean Women</brief_title>
  <official_title>Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well known fact that postoperative whole breast radiation therapy (RT) in left breast&#xD;
      cancer patient can cause cardiac problem according to the exposed dose. In the several&#xD;
      studies in other countries, it was repeatedly showed that RT on prone position can reduce&#xD;
      cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position&#xD;
      in RT is not studied in the Korean women have relatively small breast. The investigators&#xD;
      planned this study to evaluate the real efficacy of prone position in Korean breast cancer&#xD;
      treated with RT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Irradiated cardiac dose</measure>
    <time_frame>At simulation, expected average of 1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Irradiated dose of left anterior descending artery</measure>
    <time_frame>At simulation, expected average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irradiated lung dose</measure>
    <time_frame>At simulation, expected average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical target volume (volume, homogeneity index, conformity index)</measure>
    <time_frame>At simulation, expected average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irradiated dose of axillary lymphatic area</measure>
    <time_frame>At simulation, expected average of 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin change after RT</measure>
    <time_frame>At 3 months after RT completion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast shape after RT</measure>
    <time_frame>At 6 months after RT completion</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Prone position whole breast RT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Whole breast RT on prone position</intervention_name>
    <arm_group_label>Prone position whole breast RT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed left breast cancer&#xD;
&#xD;
          -  20 or older age&#xD;
&#xD;
          -  less than 70 years old&#xD;
&#xD;
          -  after curative resection&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0 to 1&#xD;
&#xD;
          -  Informed consent to this study&#xD;
&#xD;
          -  Consent to contraception for 6 months after RT completion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male breast cancer&#xD;
&#xD;
          -  Combined distant metastasis&#xD;
&#xD;
          -  Status of pregnant or brest feeding&#xD;
&#xD;
          -  Previous RT history of chest or neck area&#xD;
&#xD;
          -  Indication of supraclavicular RT&#xD;
&#xD;
          -  Not indicated postoperative whole breast RT&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Doo Ho Choi, M.D., Ph.D.</last_name>
    <phone>82-2-3410-2612</phone>
    <email>doho.choi@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Doo Ho Choi, M.D., Ph.D.</last_name>
      <phone>82-2-3410-2612</phone>
      <email>doho.choi@samsung.com</email>
    </contact>
    <investigator>
      <last_name>Doo Ho Choi, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Won Park, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yunsun Chung, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Seung Jae Huh, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeong Il Yu, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>November 6, 2014</last_update_submitted>
  <last_update_submitted_qc>November 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Doo Ho Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Korean</keyword>
  <keyword>Left side</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/NCT02231112
org study id: 2014-06-138-001
nct id: NCT02231112
lead sponsor: 
has dmc: Yes
It is well known fact that postoperative whole breast radiation therapy (RT) in left breast
      cancer patient can cause cardiac problem according to the exposed dose. In the several
      studies in other countries, it was repeatedly showed that RT on prone position can reduce
      cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position
      in RT is not studied in the Korean women have relatively small breast. The investigators
      planned this study to evaluate the real efficacy of prone position in Korean breast cancer
      treated with RT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Irradiated cardiac dose
time frame: At simulation, expected average of 1 week
measure: Irradiated dose of left anterior descending artery
time frame: At simulation, expected average of 1 week
measure: Irradiated lung dose
time frame: At simulation, expected average of 1 week
measure: Clinical target volume (volume, homogeneity index, conformity index)
time frame: At simulation, expected average of 1 week
measure: Irradiated dose of axillary lymphatic area
time frame: At simulation, expected average of 1 week
measure: Skin change after RT
time frame: At 3 months after RT completion
measure: Breast shape after RT
time frame: At 6 months after RT completion
arm group label: Prone position whole breast RT
arm group type: Experimental
intervention type: Radiation
intervention name: Whole breast RT on prone position
arm group label: Prone position whole breast RT
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Doo Ho Choi, M.D., Ph.D.
phone: 82-2-3410-2612
email: doho.choi@samsung.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Doo Ho Choi
investigator title: Professor
mesh term: Breast Neoplasms