<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/NCT03286023</url>
  </required_header>
  <id_info>
    <org_study_id>CYM6 Brain metastases CFB 1</org_study_id>
    <nct_id>NCT03286023</nct_id>
  </id_info>
  <brief_title>Stereotactic Radiotherapy for Brain Metastases</brief_title>
  <acronym>CKBrainMeta</acronym>
  <official_title>Stereotactic Radiotherapy for Patients With Brain Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse, Luxembourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Francois Baclesse, Luxembourg</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>
      Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain&#xD;
      metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity&#xD;
      of this treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of tumoral response</measure>
    <time_frame>4 weeks after treatment</time_frame>
    <description>Evaluation of response using Magnetic resonance imaging (Recist criteria)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of tumoral response</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Evaluation of response using Magnetic resonance imaging (Recist criteria)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of toxicity</measure>
    <time_frame>1, 3, 6, 9, 12, 15 months after treatment</time_frame>
    <description>Evaluation of toxicity using CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Metastasis Brain</condition>
  <arm_group>
    <arm_group_label>Stereotactic radiation</arm_group_label>
    <description>Stereotactic radiation for brain metastases</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>stereotactic radiotherapy</intervention_name>
    <description>stereotactic radiotherapy for brain metastases</description>
    <arm_group_label>Stereotactic radiation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with brain metastases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Situation 1: in case of several cerebral metastases. In this case, the maximum of&#xD;
             cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm.&#xD;
             The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the&#xD;
             two. The same principle will remain valid in the presence of 2 metastases.&#xD;
&#xD;
          -  Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3&#xD;
             cm&#xD;
&#xD;
          -  Situation 3: in case of metastasis supposed to be radioresistant (renal&#xD;
             adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm&#xD;
             in diameter will be accepted. A primary resection followed by radiotherapy will be&#xD;
             preferred.&#xD;
&#xD;
          -  Situation 4: In case of localization near a structure at risk (contact with anterior&#xD;
             optical pathways, central nuclei or the brainstem or localization in these&#xD;
             structures), a maximum number of 3 metastases may be accepted. However, that included&#xD;
             in or close to the risk structure can not exceed 2 cm in diameter and the other two,&#xD;
             located outside a risk structure will have a diameter not exceeding 1 or even maximum&#xD;
             2 cm.&#xD;
&#xD;
          -  Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the&#xD;
             whole encephalon having already received the dose of 10 X 3 Gy or its biological&#xD;
             equivalent of dose.&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibility of performing an MRI or a CT-scan of the brain with injection of&#xD;
             contrast agent&#xD;
&#xD;
          -  Metastases greater than 3 cm at the start&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Francois Baclesse</name>
      <address>
        <city>Esch-sur-Alzette</city>
        <state>SUD</state>
        <zip>L-4240</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Luxembourg</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>June 20, 2022</last_update_submitted>
  <last_update_submitted_qc>June 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brain metastases</keyword>
  <keyword>stereotactic radiation</keyword>
  <keyword>cyberknife</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03286023
org study id: CYM6 Brain metastases CFB 1
nct id: NCT03286023
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain
      metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity
      of this treatment.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of tumoral response
time frame: 4 weeks after treatment
description: Evaluation of response using Magnetic resonance imaging (Recist criteria)
measure: Evaluation of tumoral response
time frame: 8 weeks after treatment
description: Evaluation of response using Magnetic resonance imaging (Recist criteria)
measure: Evaluation of toxicity
time frame: 1, 3, 6, 9, 12, 15 months after treatment
description: Evaluation of toxicity using CTCAE v4.0
arm group label: Stereotactic radiation
description: Stereotactic radiation for brain metastases
intervention type: Radiation
intervention name: stereotactic radiotherapy
description: stereotactic radiotherapy for brain metastases
arm group label: Stereotactic radiation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Luxembourg
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
sharing ipd: No