xml: <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/NCT05992870</url>
    </required_header>
    <id_info>
      <org_study_id>NeoRTIBR</org_study_id>
      <nct_id>NCT05992870</nct_id>
    </id_info>
    <brief_title>Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction</brief_title>
    <official_title>Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hubei Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hubei Cancer Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction&#xD;
        is feasible and technically safe. However, reports of NACT followed immediate implant-based&#xD;
        breast reconstruction are rare. Some studies have shown that NART followed immediate&#xD;
        implant-based breast reconstruction seems feasible and can be safely attempted. It's well&#xD;
        known that radiotherapy after implant-based breast reconstruction have negative effects on&#xD;
        implant and cosmetic results. So, investigators conducted a polit study to learn about acute&#xD;
        post-surgical complications following skin-sparing mastectomy and immediate implant-based&#xD;
        breast reconstruction after NART.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Radiotherapy after implant-based breast reconstruction have negative effects on implant and&#xD;
        cosmetic results, including severe capsular contracture, mastectomy flap necrosis&#xD;
        ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant&#xD;
        reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by&#xD;
        skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically&#xD;
        safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects&#xD;
        of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results&#xD;
        and less complications compared to PMRT. Furthermore, some studies have shown that NART could&#xD;
        potentially result in shorter time between diagnosis and treatment completion. So,&#xD;
        investigators conducted a polit study to learn about acute post-surgical complications&#xD;
        following skin-sparing mastectomy and immediate implant-based breast reconstruction after&#xD;
        NART.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 8, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 8, 2025</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>Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART</measure>
      <time_frame>3 months following skin-sparing mastectomy and immediate breast reconstruction</time_frame>
      <description>Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .</measure>
      <time_frame>Within 3 months after both breast reconstruction and radiotherapy</time_frame>
      <description>Other adverse events following NART or surgery other than described in the primary outcome measure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with removal of implant.</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>Implant are removed for postoperative complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction.</measure>
      <time_frame>3 months and 12 months after surgery</time_frame>
      <description>Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen</measure>
      <time_frame>Within 2 weeks after skin-sparing mastectomy</time_frame>
      <description>A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Implant Breast Reconstruction</condition>
    <condition>Neoadjuvant Radiotherapy</condition>
    <arm_group>
      <arm_group_label>Neoadjuvant radiotherapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Neoadjuvant radiotherapy</intervention_name>
      <description>In case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week.&#xD;
  A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment.</description>
      <arm_group_label>Neoadjuvant radiotherapy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Women &gt;18 years with histopathologically-confirmed breast cancer, who:&#xD;
  &#xD;
            -  require mastectomy for any reason&#xD;
  &#xD;
            -  a known indication for (adjuvant) radiotherapy&#xD;
  &#xD;
            -  require implant-based breast reconstruction&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to give informed consent&#xD;
  &#xD;
            -  MDT unable to make recommendation for radiotherapy based on pre-operative&#xD;
               histopathological and imaging findings&#xD;
  &#xD;
            -  Previous history of breast cancer or another malignancy for which radiotherapy of the&#xD;
               breast or axilla&#xD;
  &#xD;
            -  Pregnant or lactating&#xD;
  &#xD;
            -  inflammatory breast cancer&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xinhong Wu, MD</last_name>
      <phone>+8618602726300</phone>
      <email>34053889@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ning Zou, MD</last_name>
      <phone>+8615007162698</phone>
      <email>sunnyning116@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Xinhong Wu</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430079</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xinhong Wu, MD</last_name>
        <phone>+8618602726300</phone>
        <email>34053889@qq.com</email>
      </contact>
      <contact_backup>
        <last_name>Ning Zou, MD</last_name>
        <phone>+8615007162698</phone>
        <email>sunnyning116@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hubei Cancer Hospital</investigator_affiliation>
      <investigator_full_name>Xinhong Wu</investigator_full_name>
      <investigator_title>vice-president</investigator_title>
    </responsible_party>
    <keyword>neoadjuvant radiotherapy, implant, breast reconstruction</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992870
  org study id: NeoRTIBR
  nct id: NCT05992870
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction
        is feasible and technically safe. However, reports of NACT followed immediate implant-based
        breast reconstruction are rare. Some studies have shown that NART followed immediate
        implant-based breast reconstruction seems feasible and can be safely attempted. It's well
        known that radiotherapy after implant-based breast reconstruction have negative effects on
        implant and cosmetic results. So, investigators conducted a polit study to learn about acute
        post-surgical complications following skin-sparing mastectomy and immediate implant-based
        breast reconstruction after NART.
  Radiotherapy after implant-based breast reconstruction have negative effects on implant and
        cosmetic results, including severe capsular contracture, mastectomy flap necrosis
        ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant
        reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by
        skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically
        safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects
        of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results
        and less complications compared to PMRT. Furthermore, some studies have shown that NART could
        potentially result in shorter time between diagnosis and treatment completion. So,
        investigators conducted a polit study to learn about acute post-surgical complications
        following skin-sparing mastectomy and immediate implant-based breast reconstruction after
        NART.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
  time frame: 3 months following skin-sparing mastectomy and immediate breast reconstruction
  description: Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .
  time frame: Within 3 months after both breast reconstruction and radiotherapy
  description: Other adverse events following NART or surgery other than described in the primary outcome measure.
  measure: Number of participants with removal of implant.
  time frame: 6 months after surgery
  description: Implant are removed for postoperative complications.
  measure: Patient satisfaction.
  time frame: 3 months and 12 months after surgery
  description: Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.
  measure: Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen
  time frame: Within 2 weeks after skin-sparing mastectomy
  description: A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).
  arm group label: Neoadjuvant radiotherapy group
  arm group type: Experimental
  description: Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH
  intervention type: Radiation
  intervention name: Neoadjuvant radiotherapy
  description: In case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week.
  A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment.
  arm group label: Neoadjuvant radiotherapy group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xinhong Wu, MD
  phone: +8618602726300
  email: 34053889@qq.com
  last name: Ning Zou, MD
  phone: +8615007162698
  email: sunnyning116@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hubei Cancer Hospital
  investigator full name: Xinhong Wu
  investigator title: vice-president
  sharing ipd: No
  ipd description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)