<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/NCT01717261</url>
  </required_header>
  <id_info>
    <org_study_id>12030</org_study_id>
    <nct_id>NCT01717261</nct_id>
  </id_info>
  <brief_title>Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer</brief_title>
  <acronym>SPORT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Maisonneuve-Rosemont Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maisonneuve-Rosemont Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if partial breast irradiation administered in a&#xD;
      single preoperative fraction is tolerable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Acute toxicity</measure>
    <time_frame>6 months</time_frame>
    <description>Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic outcome</measure>
    <time_frame>5 years</time_frame>
    <description>Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ipsilateral breast cancer recurrence</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Single Pre-Operative Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Single Pre-Operative Radiation Therapy</intervention_name>
    <description>Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.</description>
    <arm_group_label>Single Pre-Operative Radiation Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged 60 years or older.&#xD;
&#xD;
          -  Invasive ductal carcinoma.&#xD;
&#xD;
          -  Unifocal disease.&#xD;
&#xD;
          -  Tumors less than 2cm.&#xD;
&#xD;
          -  No clinical evidence of nodal disease.&#xD;
&#xD;
          -  Estrogen receptor status (ER) positive.&#xD;
&#xD;
          -  Her2 negative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 60 years.&#xD;
&#xD;
          -  BRCA 1 and/or BRCA 2 mutation.&#xD;
&#xD;
          -  Tumour histology limited to lobular carcinoma only.&#xD;
&#xD;
          -  Neoadjuvant hormonal manipulation or chemotherapy.&#xD;
&#xD;
          -  More than one primary tumour in different quadrants of the same breast.&#xD;
&#xD;
          -  Inability to view tumor on imaging.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Yassa, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Maisonneuve-Rosemon Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Yassa, MD</last_name>
    <phone>15142523425</phone>
    <email>myassa.hmr@ssss.gouv.qc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maisonneuve-Rosemont Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Linda Roy-Huneault</last_name>
      <phone>5142523425</phone>
      <email>lroyhuneault.hmr@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Michael Yassa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maisonneuve-Rosemont Hospital</investigator_affiliation>
    <investigator_full_name>Michael Yassa</investigator_full_name>
    <investigator_title>Radiation Oncologist</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>early breast cancer</keyword>
  <keyword>partial breast irradiation</keyword>
  <keyword>preoperative radiation</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/NCT01717261
org study id: 12030
nct id: NCT01717261
lead sponsor: 
has dmc: No
The purpose of this study is to determine if partial breast irradiation administered in a
      single preoperative fraction is tolerable.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute toxicity
time frame: 6 months
description: Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
measure: Chronic toxicity
time frame: 2 years
description: Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
measure: Cosmetic outcome
time frame: 5 years
description: Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.
measure: Ipsilateral breast cancer recurrence
time frame: 5 years
arm group label: Single Pre-Operative Radiation Therapy
arm group type: Experimental
intervention type: Radiation
intervention name: Single Pre-Operative Radiation Therapy
description: Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.
arm group label: Single Pre-Operative Radiation Therapy
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Yassa, MD
role: Study Chair
affiliation: Maisonneuve-Rosemon Hospital
last name: Michael Yassa, MD
phone: 15142523425
email: myassa.hmr@ssss.gouv.qc.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Maisonneuve-Rosemont Hospital
investigator full name: Michael Yassa
investigator title: Radiation Oncologist
mesh term: Breast Neoplasms