<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/NCT01706016</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00448-35</org_study_id>
    <secondary_id>2011/1773</secondary_id>
    <nct_id>NCT01706016</nct_id>
  </id_info>
  <brief_title>Local Treatment by Thermic Destruction of Primitive Breast Cancer</brief_title>
  <acronym>LASERBREAST1</acronym>
  <official_title>Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating&#xD;
      with histological analysis of the specimen the percentage of tumor cells remaining in the&#xD;
      area treated by the laser&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2012</start_date>
  <completion_date type="Actual">November 17, 2016</completion_date>
  <primary_completion_date type="Actual">November 17, 2016</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>Effectiveness of laser treatment</measure>
    <time_frame>28 days after initial diagnosis</time_frame>
    <description>Destruction of the carcinoma will be assess by histological analysis of the specimen.&#xD;
If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Life quality</measure>
    <time_frame>D-0 and before the surgery</time_frame>
    <description>Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with breast cancer smaller than 20mm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thermic destruction of tissue by Laser using the Novilase device</intervention_name>
    <arm_group_label>Patients with breast cancer smaller than 20mm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Noninflammatory unilateral and unifocal breast cancer&#xD;
&#xD;
          -  Size &lt;/= 20mm (ultrasound measure)&#xD;
&#xD;
          -  Histological confirmation of cancer by biopsy grade status hormone and HER2.&#xD;
&#xD;
          -  Good delineation of the lesion on ultrasound.&#xD;
&#xD;
          -  Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.&#xD;
&#xD;
          -  Age between 18 and 80&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Remy GARBAY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <state>Nord</state>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val De Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Lariboisière</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>March 27, 2018</last_update_submitted>
  <last_update_submitted_qc>March 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01706016
org study id: 2012-A00448-35
secondary id: 2011/1773
nct id: NCT01706016
lead sponsor: 
has dmc: No
Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating
      with histological analysis of the specimen the percentage of tumor cells remaining in the
      area treated by the laser
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of laser treatment
time frame: 28 days after initial diagnosis
description: Destruction of the carcinoma will be assess by histological analysis of the specimen.
If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail
measure: Life quality
time frame: D-0 and before the surgery
description: Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3
arm group label: Patients with breast cancer smaller than 20mm
arm group type: Experimental
intervention type: Procedure
intervention name: Thermic destruction of tissue by Laser using the Novilase device
arm group label: Patients with breast cancer smaller than 20mm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jean Remy GARBAY, MD
role: Principal Investigator
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms