<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/NCT01688388</url>
  </required_header>
  <id_info>
    <org_study_id>12-001 Single Fraction IORT</org_study_id>
    <nct_id>NCT01688388</nct_id>
  </id_info>
  <brief_title>Single Fraction Intraoperative Radiotherapy</brief_title>
  <official_title>Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph Hospital of Orange</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph Hospital of Orange</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is being conducted to find out the effects (good and bad) of giving the&#xD;
      full radiation treatment for breast cancer as a single dose of radiation during surgery for&#xD;
      breast cancer. This single fraction intraoperative radiotherapy with electrons will study the&#xD;
      toxicity, local control and cosmetic outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For patients with certain types of breast cancer, one standard treatment is breast conserving&#xD;
      surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a&#xD;
      small amount of normal tissue around it) followed by breast radiation. The radiation&#xD;
      treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized&#xD;
      irradiation (or boost) treatments at the site where the lump was removed. During this study,&#xD;
      the single dose of electron irradiation given at the surgical site during the operation will&#xD;
      replace the radiation given after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">February 2022</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</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>Toxicity Assessment</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:&#xD;
End of initial surgical phase: Week 1, 4&#xD;
First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cosmetic Evaluation</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment of cosmetic outcome according to 5-point scoring system&#xD;
Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60&#xD;
At yearly follow-up (photodocumentation in standardized positions) for 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence Assessment</measure>
    <time_frame>5 years</time_frame>
    <description>Recurrence is assessed at month 6, 12, 24, 36, 48, 60</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Invasive Ductal and Invasive Lobular Breast Carcinoma</condition>
  <condition>Stage 0 Breast Carcinoma</condition>
  <condition>Stage I Breast Carcinoma</condition>
  <condition>Stage II Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>IORT Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraoperative Radiotherapy</intervention_name>
    <description>Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.</description>
    <arm_group_label>IORT Arm</arm_group_label>
    <other_name>IORT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma&#xD;
             in situ&#xD;
&#xD;
          -  Age &gt; 40 years&#xD;
&#xD;
          -  Karnofsky performance status &gt; 70%&#xD;
&#xD;
          -  Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a&#xD;
             specimen radiograph or multifocal disease within the same quadrant with a maximum&#xD;
             dimension of equal to or less than 2.5 cm&#xD;
&#xD;
          -  Nodal Status: preoperatively N0&#xD;
&#xD;
          -  Clear surgical margins: R0&#xD;
&#xD;
          -  All grades G1 - G3&#xD;
&#xD;
          -  Any hormonal receptor and HER-2 status&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gender: male&#xD;
&#xD;
          -  Tumor size: more than 2.5 cm&#xD;
&#xD;
          -  Nodal status greater than or equal to N1 pathologically&#xD;
&#xD;
          -  Multicentricity&#xD;
&#xD;
          -  Previous radiotherapy to the involved breast&#xD;
&#xD;
          -  Karnofsky Index &lt; 70%&#xD;
&#xD;
          -  Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis&#xD;
             obliterans, systemic lupus&#xD;
&#xD;
          -  Distant metastases&#xD;
&#xD;
          -  Pregnancy in woman of child bearing age&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence Wagman, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>St. Joseph Hospital of Orange</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph Hospital of Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Carcinoma</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Intraoperative Radiotherapy</keyword>
  <keyword>IORT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Lobular</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</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/NCT01688388
org study id: 12-001 Single Fraction IORT
nct id: NCT01688388
lead sponsor: 
has dmc: No
This clinical trial is being conducted to find out the effects (good and bad) of giving the
      full radiation treatment for breast cancer as a single dose of radiation during surgery for
      breast cancer. This single fraction intraoperative radiotherapy with electrons will study the
      toxicity, local control and cosmetic outcome.
For patients with certain types of breast cancer, one standard treatment is breast conserving
      surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a
      small amount of normal tissue around it) followed by breast radiation. The radiation
      treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized
      irradiation (or boost) treatments at the site where the lump was removed. During this study,
      the single dose of electron irradiation given at the surgical site during the operation will
      replace the radiation given after surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicity Assessment
time frame: 5 years
description: Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:
End of initial surgical phase: Week 1, 4
First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months
measure: Cosmetic Evaluation
time frame: 5 years
description: Assessment of cosmetic outcome according to 5-point scoring system
Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
At yearly follow-up (photodocumentation in standardized positions) for 5 years
measure: Recurrence Assessment
time frame: 5 years
description: Recurrence is assessed at month 6, 12, 24, 36, 48, 60
arm group label: IORT Arm
arm group type: Experimental
description: Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
intervention type: Procedure
intervention name: Intraoperative Radiotherapy
description: Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
arm group label: IORT Arm
other name: IORT
criteria: 
gender: Female
minimum age: 41 Years
maximum age: 90 Years
healthy volunteers: No
last name: Lawrence Wagman, M.D.
role: Study Chair
affiliation: St. Joseph Hospital of Orange
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma, Lobular
mesh term: Breast Carcinoma In Situ