<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/NCT01727011</url>
  </required_header>
  <id_info>
    <org_study_id>2012/09 - SIFEBI</org_study_id>
    <secondary_id>2012-A00745-38</secondary_id>
    <nct_id>NCT01727011</nct_id>
  </id_info>
  <brief_title>Single Fraction Elderly Breast Irradiation (SiFEBI)</brief_title>
  <acronym>SIFEBI</acronym>
  <official_title>A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Antoine Lacassagne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Antoine Lacassagne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept&#xD;
      whose validity is being assessed on its non-inferiority in terms of local control compared to&#xD;
      whole breast irradiation. At least eight phase III trials attempting to answer this question&#xD;
      and thus provide a sufficient level of evidence to make this concept a new standard of care&#xD;
      for sub-groups of patients well defined (1).&#xD;
&#xD;
      However, without waiting for the final results of these randomized trials (which will not be&#xD;
      fully valid with a drop of at least ten years), the American societies (ASTRO) and European&#xD;
      (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups&#xD;
      according to the risk to the patient in terms of local recurrence after IPAS. And are defined&#xD;
      by the ESTRO:&#xD;
&#xD;
        -  The low-risk group (&quot;suitable&quot; for ASTRO)&#xD;
&#xD;
        -  The intermediate-risk group (&quot;cautionary&quot; in ASTRO)&#xD;
&#xD;
        -  The high-risk group (&quot;not suitable&quot; for ASTRO) (2.3). Therefore, it is possible to&#xD;
           propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group&#xD;
           &quot;low risk.&quot; The results of phase II trials as a long-term analysis of the matched team&#xD;
           of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation&#xD;
           photons in low energy X whose results were recently published (5) confirm the value of&#xD;
           this new therapeutic concept for post-operative breast cancer at low risk of local&#xD;
           recurrence.&#xD;
&#xD;
      In France, the therapists were quickly directed to a sub-population for which the IPAS could&#xD;
      represent a real improvement in the therapeutic management in significantly reducing the&#xD;
      number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6).&#xD;
      Several French phase II trials were started specifically targeting the female population aged&#xD;
      using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie&#xD;
      (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter:&#xD;
      FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health&#xD;
      Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy&#xD;
      (Radiotherapy and Oncology from 09/11/11) (9).&#xD;
&#xD;
      On a technical level, two main approaches are used (10):&#xD;
&#xD;
        -  Irradiation intraoperative electron or low-energy photons,&#xD;
&#xD;
        -  Radiation after surgery The advantage of intraoperative irradiation is the optimal&#xD;
           reduction of total processing time radio-surgery because the patient is irradiated&#xD;
           during the lumpectomy. However, 15-20% of these patients receive partial breast&#xD;
           irradiation, as histo-prognostic criteria provided in the histologically final report,&#xD;
           confirm the non-adapted indication of IPAS (5).&#xD;
&#xD;
      In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS&#xD;
      but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days&#xD;
      separated by at least 6 hours).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single dose intraoperative issued by electrontherapy or low energy photons (50 Kv) is 21 Gy&#xD;
      (5.11). However, these doses reported in the irradiated volume are not equivalent. Indeed,&#xD;
      with electrontherapy, it is a complete volume of mammary parenchyma that is irradiated,&#xD;
      whereas with low energy photon therapy (X 50 KV) is a &quot;shell&quot; of 5 mm thick which is treated&#xD;
      knowing that to 10 mm from the surface of the sphere of treatment, the gland received only&#xD;
      50% of the dose initially prescribed. On interstitial brachytherapy with high dose rate, it&#xD;
      has a dose escalation due to intrinsic volumes located within the irradiated area that will&#xD;
      receive a higher dose than prescribed (12). It is this variation in dose within the target&#xD;
      volume which can be efficiency, but also which can induce the toxicity of interstitial&#xD;
      brachytherapy. The linear quadratic model to calculate the biological equivalence of 2 Gy&#xD;
      irradiation scheme most often hypofractionned, is theoretically applicable for doses per&#xD;
      fraction less than 8 Gy. Nevertheless, the authors using the IPAS intra-operative (electrons,&#xD;
      photons) apply this method of calculation for doses of 21 Gy in one fraction.&#xD;
&#xD;
      In our study, we propose to treat these patients with a total dose of 16 Gy in one fraction.&#xD;
      This dose is calculated taking into account a report alpha/beta for the breast, on the order&#xD;
      of 3.4 Gy for late toxicity and 4.6 Gy for local control (13). Applying the linear-quadratic&#xD;
      model with alpha/beta for the breast of 4, 16 Gy in one fraction is calculated as&#xD;
      radio-biologically equivalent to 53 Gy in conventional fractionation (14,15). Biological&#xD;
      Equivalence of this dose is between the dose in the protocols IPAS intraoperative electron or&#xD;
      X-ray photons of 50 kV (21 Gy in one fraction, 87 Gy EQD2 alpha/beta 4.6) (5.8) and the&#xD;
      post-operative irradiation of 34-38 Gy in 10 fractions, 5 days (42 Gy EQD2 alpha/beta 4.6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)</measure>
    <time_frame>180 days</time_frame>
    <description>Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.&#xD;
Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the Quality of Life</measure>
    <time_frame>180 days</time_frame>
    <description>Analysis of the impact on self assessment by onco-geriatric aesthetic result evaluation Dosimetric data analysis in order to propose dose constraints for future inverse planning</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>IPAS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IPAS</intervention_name>
    <arm_group_label>IPAS</arm_group_label>
    <other_name>irradiation and partial accelerated breast brachytherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient WITHinvasive breast cancer histologically proved: ductal, lobular, medullary,&#xD;
             papillary, tubular or colloid:&#xD;
&#xD;
               -  All grades histo-prognostic&#xD;
&#xD;
               -  pT1 tumor size (&lt;20 mm),&#xD;
&#xD;
               -  healthy Margins surgical&#xD;
&#xD;
               -  unifocal lesion&#xD;
&#xD;
               -  Any hormone receptor,&#xD;
&#xD;
               -  Any Her2 status,&#xD;
&#xD;
               -  No lymph node (sentinel lymphadenectomy or) or micrometastases (pN0, pN1mic)&#xD;
&#xD;
          -  Age greater than or equal to 70 years&#xD;
&#xD;
          -  Score Balducci I or II,&#xD;
&#xD;
          -  Karnofsky index greater than or equal to 70%&#xD;
&#xD;
          -  Time between lumpectomy and radiation less than 2 weeks&#xD;
&#xD;
          -  Implementation of clips in the tumor bed intraoperatively,&#xD;
&#xD;
          -  Patient having taken note of the information note and who signed the informed consent&#xD;
&#xD;
          -  Patient receiving social security coverage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lobular carcinoma in situ or pure ductal carcinoma in situ or non-epithelial tumor&#xD;
             type sarcoma or lymphoma,&#xD;
&#xD;
          -  Component extensive ductal in situ associated&#xD;
&#xD;
          -  Peritumoral lymphatic emboli,&#xD;
&#xD;
          -  Distance Metastasis&#xD;
&#xD;
          -  Inflammatory Breast Cancer,&#xD;
&#xD;
          -  Multifocal tumor (covering a total distance inter-end of 40 mm or more)&#xD;
&#xD;
          -  Previous treatment for this tumor including breast radiotherapy and / or chemotherapy&#xD;
             neoadjuvant or adjuvant&#xD;
&#xD;
          -  History of plastic surgery breast&#xD;
&#xD;
          -  Unknown or safety margins positive for invasive carcinoma&#xD;
&#xD;
          -  Absence of clips in the tumor bed,&#xD;
&#xD;
          -  Time between lumpectomy and radiation greater than or equal to 2 weeks&#xD;
&#xD;
          -  Active infection or other serious comorbidity that could prevent the patient receiving&#xD;
             the treatment,&#xD;
&#xD;
          -  History of cancer other than a basal cell skin or carcinoma in situ of the cervix or&#xD;
             other cancer in complete remission for more than 5 years&#xD;
&#xD;
          -  Psychiatric illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Michel HANNOUN LEVI, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Antoine Lacassagne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.centreantoinelacassagne.org/</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>October 5, 2021</results_first_submitted>
  <results_first_submitted_qc>November 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2021</results_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Single fraction</keyword>
  <keyword>Elderly</keyword>
  <keyword>Breast Irradiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Irradiation and Accelerated Partial Breast (IPAS)</title>
          <description>Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction&#xD;
IPAS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IPAS</title>
          <description>Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction&#xD;
IPAS</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.6" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)</title>
        <description>Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.&#xD;
Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.</description>
        <time_frame>180 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IPAS</title>
            <description>Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction&#xD;
IPAS</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)</title>
          <description>Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.&#xD;
Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of the Quality of Life</title>
        <description>Analysis of the impact on self assessment by onco-geriatric aesthetic result evaluation Dosimetric data analysis in order to propose dose constraints for future inverse planning</description>
        <time_frame>180 days</time_frame>
        <posting_date>11/2021</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>IPAS</title>
          <description>Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction&#xD;
IPAS</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>tacchycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>left breast painful inflammatory syndroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>right breast haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>BREAST FIBROSIS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>BREAST HAEMATOMA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>BREAST PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>INJECTION SITE INFLAMMATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>SKIN HYPERPIGMENTATION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>RADIATION SKIN INJURY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professeur JM Hannoun-Levi</name_or_title>
      <organization>Centre Antoine Lacassagne</organization>
      <phone>04.92.03.12.60</phone>
      <email>jean-michel.hannoun-levi@nice.unicancer.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01727011
org study id: 2012/09 - SIFEBI
secondary id: 2012-A00745-38
nct id: NCT01727011
lead sponsor: 
has dmc: Yes
Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept
      whose validity is being assessed on its non-inferiority in terms of local control compared to
      whole breast irradiation. At least eight phase III trials attempting to answer this question
      and thus provide a sufficient level of evidence to make this concept a new standard of care
      for sub-groups of patients well defined (1).

      However, without waiting for the final results of these randomized trials (which will not be
      fully valid with a drop of at least ten years), the American societies (ASTRO) and European
      (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups
      according to the risk to the patient in terms of local recurrence after IPAS. And are defined
      by the ESTRO:

        -  The low-risk group ("suitable" for ASTRO)

        -  The intermediate-risk group ("cautionary" in ASTRO)

        -  The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to
           propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group
           "low risk." The results of phase II trials as a long-term analysis of the matched team
           of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation
           photons in low energy X whose results were recently published (5) confirm the value of
           this new therapeutic concept for post-operative breast cancer at low risk of local
           recurrence.

      In France, the therapists were quickly directed to a sub-population for which the IPAS could
      represent a real improvement in the therapeutic management in significantly reducing the
      number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6).
      Several French phase II trials were started specifically targeting the female population aged
      using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie
      (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter:
      FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health
      Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy
      (Radiotherapy and Oncology from 09/11/11) (9).

      On a technical level, two main approaches are used (10):

        -  Irradiation intraoperative electron or low-energy photons,

        -  Radiation after surgery The advantage of intraoperative irradiation is the optimal
           reduction of total processing time radio-surgery because the patient is irradiated
           during the lumpectomy. However, 15-20% of these patients receive partial breast
           irradiation, as histo-prognostic criteria provided in the histologically final report,
           confirm the non-adapted indication of IPAS (5).

      In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS
      but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days
      separated by at least 6 hours).
Single dose intraoperative issued by electrontherapy or low energy photons (50 Kv) is 21 Gy
      (5.11). However, these doses reported in the irradiated volume are not equivalent. Indeed,
      with electrontherapy, it is a complete volume of mammary parenchyma that is irradiated,
      whereas with low energy photon therapy (X 50 KV) is a "shell" of 5 mm thick which is treated
      knowing that to 10 mm from the surface of the sphere of treatment, the gland received only
      50% of the dose initially prescribed. On interstitial brachytherapy with high dose rate, it
      has a dose escalation due to intrinsic volumes located within the irradiated area that will
      receive a higher dose than prescribed (12). It is this variation in dose within the target
      volume which can be efficiency, but also which can induce the toxicity of interstitial
      brachytherapy. The linear quadratic model to calculate the biological equivalence of 2 Gy
      irradiation scheme most often hypofractionned, is theoretically applicable for doses per
      fraction less than 8 Gy. Nevertheless, the authors using the IPAS intra-operative (electrons,
      photons) apply this method of calculation for doses of 21 Gy in one fraction.

      In our study, we propose to treat these patients with a total dose of 16 Gy in one fraction.
      This dose is calculated taking into account a report alpha/beta for the breast, on the order
      of 3.4 Gy for late toxicity and 4.6 Gy for local control (13). Applying the linear-quadratic
      model with alpha/beta for the breast of 4, 16 Gy in one fraction is calculated as
      radio-biologically equivalent to 53 Gy in conventional fractionation (14,15). Biological
      Equivalence of this dose is between the dose in the protocols IPAS intraoperative electron or
      X-ray photons of 50 kV (21 Gy in one fraction, 87 Gy EQD2 alpha/beta 4.6) (5.8) and the
      post-operative irradiation of 34-38 Gy in 10 fractions, 5 days (42 Gy EQD2 alpha/beta 4.6.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)
time frame: 180 days
description: Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.
Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.
measure: Evaluation of the Quality of Life
time frame: 180 days
description: Analysis of the impact on self assessment by onco-geriatric aesthetic result evaluation Dosimetric data analysis in order to propose dose constraints for future inverse planning
arm group label: IPAS
arm group type: Experimental
description: Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction
intervention type: Radiation
intervention name: IPAS
arm group label: IPAS
other name: irradiation and partial accelerated breast brachytherapy
criteria: 
gender: Female
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Michel HANNOUN LEVI, Phd
role: Principal Investigator
affiliation: Centre Antoine Lacassagne
facility: 
country: France
url: http://www.centreantoinelacassagne.org/
description: Related Info
responsible party type: Sponsor
mesh term: Breast Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 