<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/NCT03002532</url>
  </required_header>
  <id_info>
    <org_study_id>ky-2016-9-37</org_study_id>
    <nct_id>NCT03002532</nct_id>
  </id_info>
  <brief_title>Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer</brief_title>
  <official_title>Whole Brain Irradiation With Hippocampal Sparing for Brain Metastases From Breast Cancer: Neurocognitive Function and Prognosis Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital to Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital to Academy of Military Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on evidence that radiation-induced damage to the hippocampus plays a considerable role&#xD;
      in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain&#xD;
      radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive&#xD;
      function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain&#xD;
      metastases from breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>neurocognitive function</measure>
    <time_frame>1 years</time_frame>
    <description>delayed recall using Hopkins Verbal Learning Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>Mini-Mental State Examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient-reported quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>Spitzer Quality of Life Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to intracranial progression</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival after brain metastases</measure>
    <time_frame>2.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Breast Cancer Metastatic</condition>
  <condition>Brain Metastases</condition>
  <arm_group>
    <arm_group_label>Whole-brain radiotherapy (WBRT) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hippocampal-sparing WBRT (HS-WBRT) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hippocampal-sparing whole brain radiotherapy is performed using modern intensity-modulated radiotherapy (IMRT) technique to avoid conformally the hippocampal neural stem-cell structure during WBRT. Prescription dose is 37.5 Gy in 15 fractions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>whole brain radiotherapy</intervention_name>
    <arm_group_label>Hippocampal-sparing WBRT (HS-WBRT) group</arm_group_label>
    <arm_group_label>Whole-brain radiotherapy (WBRT) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with advanced breast cancer who is confirmed historically.&#xD;
&#xD;
          -  New developing brain metastases (BM) is confirmed by gadolinium contrast-enhanced&#xD;
             magnetic resonance imaging (MRI), with or without clinical symptoms and pathology, and&#xD;
             without a history of BM treatment.&#xD;
&#xD;
          -  At least 2 BM lesions with the diameter of the largest lesion &lt; 40 mm is eligible. And&#xD;
             the distance from the border of a mass to the hippocampal margin should be more than&#xD;
             15 mm.&#xD;
&#xD;
          -  The Eastern Cooperative Oncology Group (ECOG) is from 0 to 2, and the expected life&#xD;
             expectancy is ≥3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent chemoradiation.&#xD;
&#xD;
          -  Patient who had received cranial irradiation previously.&#xD;
&#xD;
          -  Patient who are enrolled in other clinical trial at the same time.&#xD;
&#xD;
          -  Patient who has severe co-morbidity or infection.&#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_official>
    <last_name>Bing Sun, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Academy of Military Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zheng Jiang</last_name>
    <phone>861066947017</phone>
    <email>keyan307@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Affiliated Hospital of Academy of Military Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zheng Jiang</last_name>
      <phone>861066947017</phone>
      <email>keyan307@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Sun B, Huang Z, Wu S, Shen G, Cha L, Meng X, Ding L, Wang J, Song S. Incidence and relapse risk of intracranial metastases within the perihippocampal region in 314 patients with breast cancer. Radiother Oncol. 2016 Jan;118(1):181-6. doi: 10.1016/j.radonc.2015.11.010. Epub 2015 Dec 7.</citation>
    <PMID>26674923</PMID>
  </results_reference>
  <results_reference>
    <citation>Sun B, Huang Z, Wu S, Ding L, Shen G, Cha L, Wang J, Song S. Cystic brain metastasis is associated with poor prognosis in patients with advanced breast cancer. Oncotarget. 2016 Nov 8;7(45):74006-74014. doi: 10.18632/oncotarget.12176.</citation>
    <PMID>27659537</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Brain metastasis</keyword>
  <keyword>Whole brain radiotherapy</keyword>
  <keyword>Hippocampal avoidance</keyword>
  <keyword>Neurocognitive function</keyword>
  <keyword>intracranial failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Brain 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/NCT03002532
org study id: ky-2016-9-37
nct id: NCT03002532
lead sponsor: 
has dmc: Yes
Based on evidence that radiation-induced damage to the hippocampus plays a considerable role
      in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain
      radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive
      function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain
      metastases from breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: neurocognitive function
time frame: 1 years
description: delayed recall using Hopkins Verbal Learning Test
measure: quality of life
time frame: 2 years
description: Mini-Mental State Examination
measure: patient-reported quality of life
time frame: 2 years
description: Spitzer Quality of Life Index
measure: time to intracranial progression
time frame: 2 years
measure: overall survival after brain metastases
time frame: 2.5 years
arm group label: Whole-brain radiotherapy (WBRT) group
arm group type: Active Comparator
description: Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.
arm group label: Hippocampal-sparing WBRT (HS-WBRT) group
arm group type: Experimental
description: Hippocampal-sparing whole brain radiotherapy is performed using modern intensity-modulated radiotherapy (IMRT) technique to avoid conformally the hippocampal neural stem-cell structure during WBRT. Prescription dose is 37.5 Gy in 15 fractions.
intervention type: Radiation
intervention name: whole brain radiotherapy
arm group label: Hippocampal-sparing WBRT (HS-WBRT) group
arm group label: Whole-brain radiotherapy (WBRT) group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bing Sun, M.D.
role: Principal Investigator
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
last name: Zheng Jiang
phone: 861066947017
email: keyan307@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Sun B, Huang Z, Wu S, Shen G, Cha L, Meng X, Ding L, Wang J, Song S. Incidence and relapse risk of intracranial metastases within the perihippocampal region in 314 patients with breast cancer. Radiother Oncol. 2016 Jan;118(1):181-6. doi: 10.1016/j.radonc.2015.11.010. Epub 2015 Dec 7.
PMID: 26674923
citation: Sun B, Huang Z, Wu S, Ding L, Shen G, Cha L, Wang J, Song S. Cystic brain metastasis is associated with poor prognosis in patients with advanced breast cancer. Oncotarget. 2016 Nov 8;7(45):74006-74014. doi: 10.18632/oncotarget.12176.
PMID: 27659537
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
sharing ipd: No