<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/NCT02213991</url>
  </required_header>
  <id_info>
    <org_study_id>K-IORT</org_study_id>
    <nct_id>NCT02213991</nct_id>
  </id_info>
  <brief_title>Intraoperative Radiotherapy for Korean Patients With Breast Cancer</brief_title>
  <official_title>A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy&#xD;
      for the replacement of boost-external beam radiotherapy in Korean women who are candidates&#xD;
      for breast-conserving treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Local toxicity checklist&#xD;
&#xD;
        -  Hematoma needing surgical evacuation&#xD;
&#xD;
        -  Seroma needing more than three aspirations&#xD;
&#xD;
        -  Skin breakdown or delayed wound healing&#xD;
&#xD;
        -  Any complication needing surgical intervention&#xD;
&#xD;
        -  Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for&#xD;
           dermatitis, telangiectasia, pain in irradiated field, or other.&#xD;
&#xD;
        -  Any complication of RTOG toxicity grade more than 2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Actual">October 2017</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>
    <intervention_model_description>Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute local toxicity in breast receiving IORT</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Acute local toxicities of ipsilateral breast occurred within 6 months after IORT&#xD;
Local toxicity checklist&#xD;
Hematoma needing surgical evacuation&#xD;
Seroma needing more than three aspirations&#xD;
Skin breakdown or delayed wound healing&#xD;
Any complication needing surgical intervention&#xD;
Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.&#xD;
Any complication of RTOG toxicity grade more than 2&#xD;
Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32.&#xD;
Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delayed local toxicity</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Monitoring of local toxicity evaluated at 2 years and 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmesis</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local tumor recurrence in ipsillateral breast</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>IBTR rate at 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetray</measure>
    <time_frame>At time of surgery</time_frame>
    <description>-Dosimetry in tumor cavity and correlation with acute and late complication rates&#xD;
Identification of anatomical indication&#xD;
MRI volumetry (Breast-to-tumor ratio)&#xD;
Skin depth measured at preoperative US</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Intraoperative Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention:&#xD;
Intraoperative Radiotherapy&#xD;
* Operation day&#xD;
Breast conservative surgery + Intraoperative radiotherapy 20 Gy&#xD;
Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. IORT with 20Gy is followed. After IORT, applicator was out of the operative field, and usual wound closure will be done.&#xD;
* Postoperative period&#xD;
± Chemotherapy&#xD;
WBRT (46 Gy) for 4~5 weeks&#xD;
± Endocrine therapy or target therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraoperative radiotherapy using Intrabeam®</intervention_name>
    <description>Operation day&#xD;
Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity.&#xD;
Purse string suture pulles up tissues and wraps up the applicator.&#xD;
Intraoperative radiotherapy using Intrabeam® (20Gy) is followed.&#xD;
After IORT, applicator was out of the operative field, and usual wound closure will be done.&#xD;
Postoperative period&#xD;
Chemotherapy WBRT (46 Gy) for 4~5 weeks&#xD;
Endocrine therapy or target therapy</description>
    <arm_group_label>Intraoperative Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed and newly diagnosed non-metastatic operable primary breast&#xD;
             cancer&#xD;
&#xD;
          -  Primary tumor &lt;5cm, measured by ultrasonography - N0-3 (any N if resectable) and no&#xD;
             evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)&#xD;
&#xD;
          -  Age ≥18-years women with good performance status (ECOG 0-1)&#xD;
&#xD;
          -  No breast operation is allowed except diagnostic biopsy&#xD;
&#xD;
          -  Women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or unwillingness to use a reliable contraceptive method in women of&#xD;
             child-bearing potential.&#xD;
&#xD;
          -  Patients who received prior chemotherapy or radiotherapy for breast cancer&#xD;
&#xD;
          -  Patients who have history of cancer other than in situ uterine cervix cancer or&#xD;
             non-melanoma skin cancer&#xD;
&#xD;
          -  The depth of tumor from skin measured by ultrasonography is less than 1cm.&#xD;
&#xD;
          -  Contraindications to breast conservative surgery&#xD;
&#xD;
               -  Multicentric breast cancer (tumors in more than one quadrant)&#xD;
&#xD;
               -  Diffuse malignant appearing microcalcification&#xD;
&#xD;
               -  Prior therapeutic radiation to the breast region&#xD;
&#xD;
               -  Small breast, which is not possible to achieve clear margins in relation to a&#xD;
                  cosmetically acceptable result&#xD;
&#xD;
               -  History of collagen vascular disease, such as active scleroderma and active lupus&#xD;
&#xD;
          -  Postoperative exclusion&#xD;
&#xD;
               -  Patients who require re-excision due to positive resection margin&#xD;
&#xD;
               -  The depth of cavity from skin after lumpectomy is less than 0.5cm&#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>Joon Jeong, M.D. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangnam Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>135720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 13, 2018</last_update_submitted>
  <last_update_submitted_qc>February 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Joon Jeong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Breast Conservative Surgery</keyword>
  <keyword>Intraoperative Radiotherapy</keyword>
  <keyword>Local Toxicity</keyword>
  <keyword>Whole breast radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02213991
org study id: K-IORT
nct id: NCT02213991
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy
      for the replacement of boost-external beam radiotherapy in Korean women who are candidates
      for breast-conserving treatment.
Local toxicity checklist

        -  Hematoma needing surgical evacuation

        -  Seroma needing more than three aspirations

        -  Skin breakdown or delayed wound healing

        -  Any complication needing surgical intervention

        -  Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for
           dermatitis, telangiectasia, pain in irradiated field, or other.

        -  Any complication of RTOG toxicity grade more than 2
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.
primary purpose: Treatment
masking: None (Open Label)
measure: Acute local toxicity in breast receiving IORT
time frame: Up to 6 months
description: Acute local toxicities of ipsilateral breast occurred within 6 months after IORT
Local toxicity checklist
Hematoma needing surgical evacuation
Seroma needing more than three aspirations
Skin breakdown or delayed wound healing
Any complication needing surgical intervention
Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.
Any complication of RTOG toxicity grade more than 2
Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32.
Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.
measure: Delayed local toxicity
time frame: Up to 5 years
description: Monitoring of local toxicity evaluated at 2 years and 5 years
measure: Cosmesis
time frame: Up to 2 years
description: Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0
measure: Local tumor recurrence in ipsillateral breast
time frame: Up to 5 years
description: IBTR rate at 5 years
measure: Dosimetray
time frame: At time of surgery
description: -Dosimetry in tumor cavity and correlation with acute and late complication rates
Identification of anatomical indication
MRI volumetry (Breast-to-tumor ratio)
Skin depth measured at preoperative US
arm group label: Intraoperative Radiotherapy
arm group type: Experimental
description: Intervention:
Intraoperative Radiotherapy
* Operation day
Breast conservative surgery + Intraoperative radiotherapy 20 Gy
Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. IORT with 20Gy is followed. After IORT, applicator was out of the operative field, and usual wound closure will be done.
* Postoperative period
± Chemotherapy
WBRT (46 Gy) for 4~5 weeks
± Endocrine therapy or target therapy
intervention type: Device
intervention name: Intraoperative radiotherapy using Intrabeam®
description: Operation day
Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity.
Purse string suture pulles up tissues and wraps up the applicator.
Intraoperative radiotherapy using Intrabeam® (20Gy) is followed.
After IORT, applicator was out of the operative field, and usual wound closure will be done.
Postoperative period
Chemotherapy WBRT (46 Gy) for 4~5 weeks
Endocrine therapy or target therapy
arm group label: Intraoperative Radiotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joon Jeong, M.D. Ph.D.
role: Principal Investigator
affiliation: Gangnam Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Joon Jeong
investigator title: Professor
mesh term: Breast Neoplasms
sharing ipd: Undecided