<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/NCT04413409</url>
  </required_header>
  <id_info>
    <org_study_id>FUSCC-OMIT</org_study_id>
    <nct_id>NCT04413409</nct_id>
  </id_info>
  <brief_title>A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)</brief_title>
  <official_title>A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in&#xD;
      patients with oligo-metastatic breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 10, 2019</start_date>
  <completion_date type="Anticipated">March 10, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2023</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>Overall Survival</measure>
    <time_frame>3-year</time_frame>
    <description>Overall survival is calculated from randomization to death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time To Event (TTE)</measure>
    <time_frame>From date of randomization at baseline to the time of the first event, assessed up to 60 months</time_frame>
    <description>From date of randomization at baseline to the time of the first event (Disease progression, local recurrence or distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause), whichever came first, assessed up to 60 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">172</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>surgical group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The metastatic sites are firstly treated by surgery then followed by systemic treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>systemic group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After confirmation of puncture, receive systemic treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Metastasectomy for the metastatic sites</intervention_name>
    <description>patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy</description>
    <arm_group_label>surgical group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. women aged 18-70 years old;&#xD;
&#xD;
          2. ECOG score: 0-2 points;&#xD;
&#xD;
          3. the expected life period is more than 3 months;&#xD;
&#xD;
          4. Histologically confirmed metastatic breast cancer: locations include central lung&#xD;
             lesions, peripheral lung lesions or liver metastases;&#xD;
&#xD;
          5. PET-CT or other imaging showed patients with ≤3 metastastatic sites, involving 1-2&#xD;
             organs mentioned above, single lesion ≤5cm;&#xD;
&#xD;
          6. according to the RECIST 1.1 edition, there is at least one measurable lesion;&#xD;
&#xD;
          7. the main organs are functioning normally, meeting the following criteria: Blood&#xD;
             routine: Hb &gt; 90g/L (no blood transfusion within 14 days); ANC &gt; 1.5 x 109/L; PLT &gt; 75&#xD;
             * 109/L;Liver function: total bilirubin TBIL is less than 1.5 x ULN (upper limit of&#xD;
             normal value); ALT and AST are less than 3 x ULN; if there is liver metastasis, ALT&#xD;
             and AST are less than 5 x ULN;Renal function: serum creatinine &lt; 1 x ULN;&#xD;
&#xD;
          8. participants voluntarily joined the study, signed informed consent, and followed up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the number of metastastatic sites ≥ 3, or the surgeon determines that the R0 resection&#xD;
             cannot be achieved;&#xD;
&#xD;
          2. with metastatic lesions other than liver or lung&#xD;
&#xD;
          3. patients with local recurrence&#xD;
&#xD;
          4. palliative radiation therapy or interventional therapy have been performed previously&#xD;
             for metastatic lesions&#xD;
&#xD;
          5. has received systemic treatment for metastatic disease, such as chemotherapy, targeted&#xD;
             therapy, endocrine therapy, immunotherapy, etc.&#xD;
&#xD;
          6. pregnant or lactating women, women of childbearing age who cannot practice effective&#xD;
             contraceptives;&#xD;
&#xD;
          7. involvement in clinical trials of unlisted drugs within 4 weeks before the start of&#xD;
             this study;&#xD;
&#xD;
          8. severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ZhiMin Shao, MD, PhD</last_name>
    <phone>+86-21-64175590</phone>
    <phone_ext>8808</phone_ext>
    <email>zhimingshao@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhimin shao</last_name>
      <phone>+86-21-64175590</phone>
      <phone_ext>8808</phone_ext>
      <email>zhimingshao@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhimin Shao</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>metastasectomy</keyword>
  <keyword>oligo-metastatic breast cancer</keyword>
  <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>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413409
org study id: FUSCC-OMIT
nct id: NCT04413409
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in
      patients with oligo-metastatic breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: 3-year
description: Overall survival is calculated from randomization to death from any cause
measure: Time To Event (TTE)
time frame: From date of randomization at baseline to the time of the first event, assessed up to 60 months
description: From date of randomization at baseline to the time of the first event (Disease progression, local recurrence or distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause), whichever came first, assessed up to 60 months
arm group label: surgical group
arm group type: Experimental
description: The metastatic sites are firstly treated by surgery then followed by systemic treatment
arm group label: systemic group
arm group type: No Intervention
description: After confirmation of puncture, receive systemic treatment
intervention type: Procedure
intervention name: Metastasectomy for the metastatic sites
description: patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy
arm group label: surgical group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: ZhiMin Shao, MD, PhD
phone: +86-21-64175590
phone ext: 8808
email: zhimingshao@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhimin Shao
investigator title: Chief Physician
mesh term: Breast Neoplasms
sharing ipd: No