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/NCT05976412</url>
    </required_header>
    <id_info>
      <org_study_id>2023（148）</org_study_id>
      <nct_id>NCT05976412</nct_id>
    </id_info>
    <brief_title>Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer</brief_title>
    <official_title>Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ruijin Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a non blind, randomized controlled study, whose hypothesis was that chest&#xD;
        wall/whole breast combined regional lymph node radiotherapy can improve the 5-year&#xD;
        disease-free survival rate of clinical high-risk pN0 breast cancer patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2031</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2031</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>5 year disease free survival rate</measure>
      <time_frame>5 year</time_frame>
      <description>Disease free survival rate from randomization to 5 years after radiotherapy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>5 year local reginal recurrence rate</measure>
      <time_frame>5 year</time_frame>
      <description>The proportion of local or regional recurrence from randomization to 5 years after radiotherapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 year distant metastases rate</measure>
      <time_frame>5 year</time_frame>
      <description>The proportion of distant metastases occurring 5 years after radiotherapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 year overall survival rate</measure>
      <time_frame>5 year</time_frame>
      <description>The proportion of death occurring 5 years after radiotherapy</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1355</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>RNI group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>non-RNI group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Regional lymph node radiotherapy</intervention_name>
      <description>Regional lymph node radiotherapy</description>
      <arm_group_label>RNI group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>chest/whole breast irradiation</intervention_name>
      <description>chest/whole breast irradiation</description>
      <arm_group_label>RNI group</arm_group_label>
      <arm_group_label>non-RNI group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Voluntarily participate and sign an informed consent form; Age&gt;18 years old, female；&#xD;
          received radical surgery for breast cancer, including breast conservation surgery or&#xD;
          mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection；&#xD;
          Invasive cancer, postoperative axillary lymph node negative, with pathological staging of&#xD;
          T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four&#xD;
          clinical high-risk recurrence factors [tumor size (&gt;2cm), tumor site (medial and central&#xD;
          quadrants), Ki-67 level (&gt;14%), and vascular status (positive)]; KPS ≥ 80, estimated&#xD;
          survival time &gt;5 years; Complete healing of Surgical incision, no incision infection, etc;&#xD;
          Reproductive period women should undergo contraception for at least one month before study,&#xD;
          and promise to use contraception throughout the entire study period and continue until the&#xD;
          specified time after the end of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic&#xD;
          medical complications that affect the implementation of radiotherapy; History of malignant&#xD;
          tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell&#xD;
          carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ);&#xD;
          Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral&#xD;
          axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by&#xD;
          pathology or imaging;&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dan Ou, MD</last_name>
      <phone>8618801970632</phone>
      <email>od12341@rjh.com.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ruijin Hospital, Shanghai jiaotong univestigy school of medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yifeng Wang</last_name>
        <phone>+862164370045</phone>
        <email>qwx12055@rjh.com.cn</email>
      </contact>
      <investigator>
        <last_name>Jiayi Chen, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
      <investigator_full_name>JIAYI CHEN</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05976412
  org study id: 2023（148）
  nct id: NCT05976412
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a non blind, randomized controlled study, whose hypothesis was that chest
        wall/whole breast combined regional lymph node radiotherapy can improve the 5-year
        disease-free survival rate of clinical high-risk pN0 breast cancer patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 5 year disease free survival rate
  time frame: 5 year
  description: Disease free survival rate from randomization to 5 years after radiotherapy
  measure: 5 year local reginal recurrence rate
  time frame: 5 year
  description: The proportion of local or regional recurrence from randomization to 5 years after radiotherapy
  measure: 5 year distant metastases rate
  time frame: 5 year
  description: The proportion of distant metastases occurring 5 years after radiotherapy
  measure: 5 year overall survival rate
  time frame: 5 year
  description: The proportion of death occurring 5 years after radiotherapy
  arm group label: RNI group
  arm group type: Experimental
  arm group label: non-RNI group
  arm group type: Placebo Comparator
  intervention type: Radiation
  intervention name: Regional lymph node radiotherapy
  description: Regional lymph node radiotherapy
  arm group label: RNI group
  intervention type: Radiation
  intervention name: chest/whole breast irradiation
  description: chest/whole breast irradiation
  arm group label: RNI group
  arm group label: non-RNI group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dan Ou, MD
  phone: 8618801970632
  email: od12341@rjh.com.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Ruijin Hospital
  investigator full name: JIAYI CHEN
  investigator title: Prof
  mesh term: Breast Neoplasms
  sharing ipd: Undecided