<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/NCT01664091</url>
  </required_header>
  <id_info>
    <org_study_id>09-254</org_study_id>
    <nct_id>NCT01664091</nct_id>
  </id_info>
  <brief_title>Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT</brief_title>
  <official_title>An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is being done to carefully evaluate the effect of giving radiation&#xD;
      therapy after temporary breast reconstruction. The investigators want to see if this type of&#xD;
      reconstruction combined with radiation will look better (once the final reconstruction has&#xD;
      been completed) and will reduce the risk that the participant will develop complications that&#xD;
      sometimes occur with other kinds of reconstruction procedures. The investigators also want to&#xD;
      know if it is easier to give the radiation with this type of reconstruction than with other&#xD;
      kinds of reconstruction procedures. The reconstruction procedure involves the temporary use&#xD;
      of a tissue expander and an acellular dermal matrix (ADM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  ADMs have been used in combination with a tissue expander and radiotherapy but have not&#xD;
           been studied formally in terms of their ability to avoid complications sometimes seen&#xD;
           with other methods of reconstruction and improve the delivery of the radiation. The only&#xD;
           difference between being on the study and not being on the study is that the research&#xD;
           team will analyze the records of those who participate to see how easy it was to give&#xD;
           the radiation, how good the cosmetic outcome of the reconstruction is and what, if any,&#xD;
           complications occured.&#xD;
&#xD;
        -  A minimum of 6 weeks between the surgery and the start of radiation therapy is required&#xD;
           to allow for adequate healing. Often this interval will be longer, as many patients will&#xD;
           receive chemotherapy in the interim. There is no maximum time from surgery to radiation.&#xD;
&#xD;
        -  Around the time of radiation planning, the radiation oncologist and plastic surgeon will&#xD;
           agree upon how much deflation of the tissue expander will be required to permit&#xD;
           simulation of the radiation therapy.&#xD;
&#xD;
        -  Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given&#xD;
           once daily Monday through Friday over 5-7 weeks.&#xD;
&#xD;
        -  After the completion of the radiation therapy, the tissue expander will be re-expanded&#xD;
           and eventually replaced by the permanent implant or flap reconstruction at the&#xD;
           discretion of the plastic surgeon.&#xD;
&#xD;
        -  Participants will be expected to return to the Radiation Oncology Clinic for follow-up&#xD;
           visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of&#xD;
           cosmetic results and complications will be done at these visits using a recognized&#xD;
           scoring system and photographs taken at each time point and scored for specific items&#xD;
           (necrosis, telangiectasia, etc).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2009</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Success Rate</measure>
    <time_frame>2 years</time_frame>
    <description>Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung Dose-Volume</measure>
    <time_frame>Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.</time_frame>
    <description>Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic Score</measure>
    <time_frame>2 years</time_frame>
    <description>Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baker Classification Peak Score</measure>
    <time_frame>Assessed up to 2 years post PMRT</time_frame>
    <description>An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baker Classification 2-Year Score</measure>
    <time_frame>2 Years</time_frame>
    <description>An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>TE-ADM with PMRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>post-mastectomy radiation therapy (PMRT)</intervention_name>
    <arm_group_label>TE-ADM with PMRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tissue expander (TE)</intervention_name>
    <arm_group_label>TE-ADM with PMRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acellular dermal matrix (ADM)</intervention_name>
    <arm_group_label>TE-ADM with PMRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3&#xD;
             invasive tumors recently treated with mastectomy&#xD;
&#xD;
          -  Patients must have had immediate reconstruction with a TE and ADM&#xD;
&#xD;
          -  Participants must be candidates for postmastectomy radiation therapy (RT).&#xD;
             Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1&#xD;
             (or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2&#xD;
             tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors&#xD;
&#xD;
          -  Axillary nodes may be positive or negative&#xD;
&#xD;
          -  Microscopically positive margins are permitted&#xD;
&#xD;
          -  Systemic therapy as recommended by a medical oncologist, pre-or post-mastectomy, is&#xD;
             permitted&#xD;
&#xD;
          -  Patients must agree to return for scheduled follow-up visits with their radiation&#xD;
             oncologist 6, 12, 18 and 24 months after RT (+/- 1 month)&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with T4 tumors&#xD;
&#xD;
          -  Participants with recurrent breast cancer or a history of prior breast RT&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant women are excluded from this study&#xD;
&#xD;
          -  Individuals with a history of a different malignancy are ineligible except for the&#xD;
             following circumstances. Individuals with a history of other malignancies are eligible&#xD;
             if they have been disease-free for at least 5 years and are deemed by the investigator&#xD;
             to be at low risk for recurrence of that malignancy. Individuals with the following&#xD;
             cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer&#xD;
             in situ, and basal cell or squamous cell carcinoma of the skin&#xD;
&#xD;
          -  HIV-positive individuals on combination antiretroviral therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Wong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 22, 2011</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>June 18, 2019</results_first_submitted>
  <results_first_submitted_qc>August 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 26, 2019</results_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Julia S. Wong, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>tissue expander</keyword>
  <keyword>acellular dermal matrix</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants enrolled from September 2009 through September 2012.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>TE-ADM With PMRT</title>
          <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </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="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tissue Expander and Acellular Dermal Matrix</title>
          <description>immediate reconstruction with a TE and ADM followed by PMRT&#xD;
radiation: The prescribed chest-wall dose will be 50 - 50.4 Gy in 25-28 fractions, given once daily over 5-7 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.3" lower_limit="24.6" upper_limit="63.5"/>
                  </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="32"/>
                  </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>Breast Cancer Laterality</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Left</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mastectomy (unilateral, bilateral)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Unilateral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bilateral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Lymph Nodes Excised</title>
          <description>Per Table 1 [Clinical and Treatment Characteristiscs], 'Lymph nodes' is a baseline variable further broken down to : 'No. Lymph Nodes involved' and 'No. Lymph Nodes excised'.&#xD;
For further information please reference Atkins et al. Effects of Postmastectomy Radiation Therapy on Immediate Tissue Expander and Acellular Dermal Matrix Reconstruction: Results of a Prospective Clinical Trial.</description>
          <units>lymph nodes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11" lower_limit="1" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Lymph Nodes Involved</title>
          <description>Per Table 1 [Clinical and Treatment Characteristiscs], 'Lymph nodes' is a baseline variable further broken down to : 'No. Lymph Nodes involved' and 'No. Lymph Nodes excised'.&#xD;
For further information please reference Atkins et al. Effects of Postmastectomy Radiation Therapy on Immediate Tissue Expander and Acellular Dermal Matrix Reconstruction: Results of a Prospective Clinical Trial.</description>
          <units>lymph nodes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Success Rate</title>
        <description>Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).</description>
        <time_frame>2 years</time_frame>
        <population>The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.</population>
        <group_list>
          <group group_id="O1">
            <title>TE-ADM With PMRT</title>
            <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate</title>
          <description>Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).</description>
          <population>The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <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="65.4" lower_limit="44.3" upper_limit="82.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lung Dose-Volume</title>
        <description>Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.</description>
        <time_frame>Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.</time_frame>
        <population>The analysis population is comprised of all enrolled participants.</population>
        <group_list>
          <group group_id="O1">
            <title>TE-ADM With PMRT</title>
            <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Dose-Volume</title>
          <description>Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.</description>
          <population>The analysis population is comprised of all enrolled participants.</population>
          <units>percentage radiation dose to lung</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" lower_limit="6.8" upper_limit="38.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cosmetic Score</title>
        <description>Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.</description>
        <time_frame>2 years</time_frame>
        <population>The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.</population>
        <group_list>
          <group group_id="O1">
            <title>TE-ADM With PMRT</title>
            <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmetic Score</title>
          <description>Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.</description>
          <population>The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baker Classification Peak Score</title>
        <description>An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.</description>
        <time_frame>Assessed up to 2 years post PMRT</time_frame>
        <population>The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT.</population>
        <group_list>
          <group group_id="O1">
            <title>TE-ADM With PMRT</title>
            <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.</description>
          </group>
        </group_list>
        <measure>
          <title>Baker Classification Peak Score</title>
          <description>An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.</description>
          <population>The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>IA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IB</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baker Classification 2-Year Score</title>
        <description>An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.</description>
        <time_frame>2 Years</time_frame>
        <population>The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.</population>
        <group_list>
          <group group_id="O1">
            <title>TE-ADM With PMRT</title>
            <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.</description>
          </group>
        </group_list>
        <measure>
          <title>Baker Classification 2-Year Score</title>
          <description>An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.</description>
          <population>The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>IA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IB</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Specific adverse events (AEs) as listed were evaluated and reported on the follow-up and cosmetic evaluation case report form at 6-, 12-, 18- and 24 months post RT. AEs were graded according to 5 classifications: mild, mild-moderate, moderate, moderate-severe and severe. Serious AEs were defined as AEs with a classification of moderate-severe or severe and other AEs with a classification of mild, mild-moderate or moderate.</time_frame>
      <desc>The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT.</desc>
      <group_list>
        <group group_id="E1">
          <title>TE-ADM With PMRT</title>
          <description>Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Deflation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Asymmetry</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Delayed Healing Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="30" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain/costochondritis</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Asymmetry</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Deflation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Delayed Healing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Skin Ischemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Chronic Drainage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="31"/>
              </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>
    <limitations_and_caveats>The major limitation of this study was its small sample size and its single arm nature.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Julia Wong, MD</name_or_title>
      <organization>Dana-Farber Cancer Institute</organization>
      <phone>617-632-3591</phone>
      <email>JWONG@LROC.HARVARD.EDU</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/NCT01664091
org study id: 09-254
nct id: NCT01664091
lead sponsor: 
collaborator: 
has dmc: Yes
This research study is being done to carefully evaluate the effect of giving radiation
      therapy after temporary breast reconstruction. The investigators want to see if this type of
      reconstruction combined with radiation will look better (once the final reconstruction has
      been completed) and will reduce the risk that the participant will develop complications that
      sometimes occur with other kinds of reconstruction procedures. The investigators also want to
      know if it is easier to give the radiation with this type of reconstruction than with other
      kinds of reconstruction procedures. The reconstruction procedure involves the temporary use
      of a tissue expander and an acellular dermal matrix (ADM).
-  ADMs have been used in combination with a tissue expander and radiotherapy but have not
           been studied formally in terms of their ability to avoid complications sometimes seen
           with other methods of reconstruction and improve the delivery of the radiation. The only
           difference between being on the study and not being on the study is that the research
           team will analyze the records of those who participate to see how easy it was to give
           the radiation, how good the cosmetic outcome of the reconstruction is and what, if any,
           complications occured.

        -  A minimum of 6 weeks between the surgery and the start of radiation therapy is required
           to allow for adequate healing. Often this interval will be longer, as many patients will
           receive chemotherapy in the interim. There is no maximum time from surgery to radiation.

        -  Around the time of radiation planning, the radiation oncologist and plastic surgeon will
           agree upon how much deflation of the tissue expander will be required to permit
           simulation of the radiation therapy.

        -  Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given
           once daily Monday through Friday over 5-7 weeks.

        -  After the completion of the radiation therapy, the tissue expander will be re-expanded
           and eventually replaced by the permanent implant or flap reconstruction at the
           discretion of the plastic surgeon.

        -  Participants will be expected to return to the Radiation Oncology Clinic for follow-up
           visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of
           cosmetic results and complications will be done at these visits using a recognized
           scoring system and photographs taken at each time point and scored for specific items
           (necrosis, telangiectasia, etc).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success Rate
time frame: 2 years
description: Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).
measure: Lung Dose-Volume
time frame: Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.
description: Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.
measure: Cosmetic Score
time frame: 2 years
description: Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.
measure: Baker Classification Peak Score
time frame: Assessed up to 2 years post PMRT
description: An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.
measure: Baker Classification 2-Year Score
time frame: 2 Years
description: An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.
arm group label: TE-ADM with PMRT
arm group type: Experimental
description: Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT.
intervention type: Radiation
intervention name: post-mastectomy radiation therapy (PMRT)
arm group label: TE-ADM with PMRT
intervention type: Device
intervention name: tissue expander (TE)
arm group label: TE-ADM with PMRT
intervention type: Device
intervention name: acellular dermal matrix (ADM)
arm group label: TE-ADM with PMRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julia Wong, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Julia S. Wong, MD
investigator title: Principal Investigator
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The major limitation of this study was its small sample size and its single arm nature.
point of contact: 