<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/NCT03027544</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2014 YZ-14</org_study_id>
    <nct_id>NCT03027544</nct_id>
  </id_info>
  <brief_title>Tomotherapy for Refractory Brain Metastases</brief_title>
  <acronym>TRBM</acronym>
  <official_title>Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
      This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy&#xD;
      for refractory brain metastases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm, single center, phase II trial to investigate the feasibility and&#xD;
      toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple&#xD;
      brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no&#xD;
      smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Objective response rate</measure>
    <time_frame>2-3 months after radiation</time_frame>
    <description>Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progress free survival rate</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local control rate</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intracranial progress free survival rate</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>from the day of radiation, up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cause of death</measure>
    <time_frame>from the day of radiation to death date, up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Brain Metastases</condition>
  <arm_group>
    <arm_group_label>experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases.&#xD;
Intervention：tomotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>tomotherapy</intervention_name>
    <description>Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions&lt;2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.&#xD;
TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.</description>
    <arm_group_label>experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by&#xD;
             enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no&#xD;
             smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain&#xD;
             tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential&#xD;
             structures of the brain, such as brain stem, optic chiasma, optic tract, etc; KPS&#xD;
             ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is&#xD;
             adjacent to the motor function areas; Age: 18-75 years old;&#xD;
&#xD;
        Adequate end-organ function:&#xD;
&#xD;
        WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤&#xD;
        1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Other clinically significant diseases (e.g.myocardial infarction within the past 6&#xD;
             months, severe arrhythmia).&#xD;
&#xD;
               -  Unable or unwilling to comply with the study protocol.&#xD;
&#xD;
               -  The expected survival time is less than 3 months.&#xD;
&#xD;
               -  Patients who are anticipated in other clinical trials of brain metastases.&#xD;
&#xD;
               -  Patients who has been treated with SRT in other hospitals&#xD;
&#xD;
               -  Pregnant patients or female patients whose HCG is positive&#xD;
&#xD;
               -  Unsuitable to participate in study, that in the opinion of the treating&#xD;
                  physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianping Xiao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianping Xiao</last_name>
    <phone>86-13811026919</phone>
    <email>jpxiao8@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianping Xiao</last_name>
      <phone>86-13811026919</phone>
      <email>jpxiao8@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Jianping Xiao</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>multiple brain metastases</keyword>
  <keyword>large brain metastases</keyword>
  <keyword>meningeal metastases</keyword>
  <keyword>tomotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Neoplasms, Second Primary</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>the baseline characteristics and treatment plan can be shared with other researchers when the research paper has been published. The IPD will be sent by email if applied.</ipd_description>
  </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/NCT03027544
org study id: NCC2014 YZ-14
nct id: NCT03027544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy
      for refractory brain metastases.
This is a single-arm, single center, phase II trial to investigate the feasibility and
      toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple
      brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no
      smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: 2-3 months after radiation
description: Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
measure: Overall survival rate
time frame: up to 3 years
measure: progress free survival rate
time frame: up to 1 year
measure: local control rate
time frame: up to 1 year
measure: intracranial progress free survival rate
time frame: up to 1 year
measure: adverse event
time frame: from the day of radiation, up to 6 months
measure: cause of death
time frame: from the day of radiation to death date, up to 5 years
arm group label: experimental arm
arm group type: Experimental
description: Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases.
Intervention：tomotherapy
intervention type: Radiation
intervention name: tomotherapy
description: Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.
TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.
arm group label: experimental arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianping Xiao
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Jianping Xiao
phone: 86-13811026919
email: jpxiao8@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Jianping Xiao
investigator title: Dr
mesh term: Neoplasm Metastasis
mesh term: Neoplasms, Second Primary
mesh term: Brain Neoplasms
sharing ipd: No
ipd description: the baseline characteristics and treatment plan can be shared with other researchers when the research paper has been published. The IPD will be sent by email if applied.