<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/NCT03000816</url>
  </required_header>
  <id_info>
    <org_study_id>ESO-Shanghai10</org_study_id>
    <nct_id>NCT03000816</nct_id>
  </id_info>
  <brief_title>A Study of SBRT for OligoMetastatic ESCC</brief_title>
  <official_title>A Phase 2 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastatic Esophageal Squamous Cell Carcinoma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this phase II trial is to assess progress-free survival, local control, overall&#xD;
      survival, safety and tolerability of SBRT to treat patients with oligometastases in&#xD;
      esophageal squamous cell carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Progression-free survival</measure>
    <time_frame>The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years</time_frame>
    <description>progression-free survival will be measured as time to either progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local control</measure>
    <time_frame>the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.</time_frame>
    <description>Local control will be measured as time to local recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.</time_frame>
    <description>Overall survival will be measured as time until death from any cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma Metastatic</condition>
  <arm_group>
    <arm_group_label>Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SBRT</intervention_name>
    <description>Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT.</description>
    <arm_group_label>Experimental Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with metastatic esophageal squamous cell carcinoma who have received initial&#xD;
             treatment for the primary site including surgery or chemoradiotherapy. Primary tumor&#xD;
             site without progression at registration. The sites of allowed metastases are:&#xD;
             peripheral lung, central lung, medistinal/cervical lymph node, liver,&#xD;
             spinal/paraspinal, osseous, and abdominal-pelvic lymph node. All metastases not&#xD;
             resected must be amenable to SBRT.&#xD;
&#xD;
          2. 1-4 radiographically distinct metastases of any distribution in 2 or less allowed&#xD;
             anatomical sites. The diameters of lesions should be less than or equal to 5cm.&#xD;
&#xD;
          3. Initial treatment should be completed at least 3 months prior to study registration.&#xD;
&#xD;
          4. All the metastases treated with SBRT should not be treated with surgery, radiation,&#xD;
             radio frequency ablation or other regional therapeutic modalities prior to study&#xD;
             registration. The other (s) lesions should have been surgically removed.&#xD;
&#xD;
          5. Age ≥ 18. PS ECOG 0-2，wight loss&lt;30% during the latest 6 months.&#xD;
&#xD;
          6. Evaluation by a radiation oncologist that the patient could tolerate the treatment of&#xD;
             SBRT.&#xD;
&#xD;
          7. Patient must provide study specific informed consent prior to study entry.&#xD;
&#xD;
          8. For females of child-bearing potential, negative serum/urine pregnancy test within 14&#xD;
             days prior to study registration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Progression of primary tumor site at time of registration.&#xD;
&#xD;
          2. Metastases with indistinct borders making targeting not feasible.&#xD;
&#xD;
          3. Known brain metastases.&#xD;
&#xD;
          4. Prior palliative radiotherapy to metastases.&#xD;
&#xD;
          5. Metastases located within 3 cm of the previously irradiated structures:&#xD;
&#xD;
             a).Spinal cord previously irradiated &gt;80Gy(Biological equivalent dose with α/β=2),&#xD;
             b).Brachial plexus previously irradiated to &gt; 100Gy(Biological equivalent dose with&#xD;
             α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to &gt;&#xD;
             90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with&#xD;
             prior V20Gy &gt; 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.&#xD;
&#xD;
          6. Pregnant or breast-feeding women or people during the birth-period who refused to take&#xD;
             contraceptives.&#xD;
&#xD;
          7. Drug addiction,Alcoholism or AIDS.&#xD;
&#xD;
          8. Patients with severe organ dysfunction or Acute bacterial or fungal infection who are&#xD;
             considered not suitable to enroll the study at the time of registration.&#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>Kuaile Zhao, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan Universtiy Shanghai Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fudan Universtiy Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Kuai Le Zhao, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</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/NCT03000816
org study id: ESO-Shanghai10
nct id: NCT03000816
lead sponsor: 
has dmc: Yes
The aim of this phase II trial is to assess progress-free survival, local control, overall
      survival, safety and tolerability of SBRT to treat patients with oligometastases in
      esophageal squamous cell carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
description: progression-free survival will be measured as time to either progression or death
measure: Local control
time frame: the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
description: Local control will be measured as time to local recurrence
measure: overall survival
time frame: The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.
description: Overall survival will be measured as time until death from any cause
arm group label: Experimental Arm
arm group type: Experimental
description: Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.
intervention type: Radiation
intervention name: SBRT
description: Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT.
arm group label: Experimental Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kuaile Zhao, MD.
role: Study Chair
affiliation: Fudan Universtiy Shanghai Cancer Center
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Kuai Le Zhao, MD
investigator title: Professor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
sharing ipd: No