<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/NCT03285932</url>
  </required_header>
  <id_info>
    <org_study_id>ESTRON</org_study_id>
    <nct_id>NCT03285932</nct_id>
  </id_info>
  <brief_title>Stereotactic Radiotherapy of the Resection Cavity of Brain Metastases vs. Post-operative Whole-brain Radiotherapy</brief_title>
  <acronym>ESTRON</acronym>
  <official_title>Evaluation of Stereotactic Radiotherapy of the Resection Cavity After Surgery of Brain Metastases Compared to Post-operative Whole-brain Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Juergen Debus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Heidelberg</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>
      In advanced cancer disease brain metastases are common, difficult to treat, and are&#xD;
      associated with a poor prognosis. As new local and systemic therapies are eventually&#xD;
      resulting in improved survival and quality of life for patients with brain metastases,&#xD;
      negative neurocognitive effects of radiation therapy are becoming increasingly important as&#xD;
      well as good loco-regional disease control of brain metastases.&#xD;
&#xD;
      Concerning treatment, brain metastases remain a major clinical problem and a&#xD;
      multidisciplinary approach to management should be adopted. Neurosurgical resection with&#xD;
      postoperative whole brain radiotherapy (WBRT) is one major treatment option in solitary or&#xD;
      symptomatic brain metastases. Furthermore, WBRT is recommended for multiple brain metastases.&#xD;
      For a limited number of brain metastases stereotactic radiosurgery (SRS) has been established&#xD;
      as a highly effective treatment alternative.&#xD;
&#xD;
      Recently, a new treatment approach combing neurosurgery with postoperative stereotactic&#xD;
      radiotherapy (SRT) of the resection cavity is emerging. Based on available evidence,&#xD;
      postoperative SRT of the resection cavity improves local control following surgery, reduces&#xD;
      the number of patients who require whole brain radiotherapy, and is well tolerated (1).&#xD;
&#xD;
      This protocol is aimed at primarily evaluating the safety and toxicity profile of SRT to the&#xD;
      resection cavity following neurosurgical resection combined with SRT of potentially further&#xD;
      unresected brain metastases, compared to postoperative whole-brain radiotherapy (WBRT).&#xD;
      Secondary, the local effect of SRT in patients with brain metastases will be assessed by&#xD;
      measuring time to local recurrence (LR), local and loco-regional progression-free survival&#xD;
      (PFS).&#xD;
&#xD;
      Additional systemic treatment will be carried out according to the standards of the National&#xD;
      Center for Tumor Therapy (NCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scientific Background: Brain metastases (BM) represent a significant healthcare problem. It&#xD;
      is estimated that 20% to 40% of patients with cancer will develop metastatic cancer to the&#xD;
      brain during the course of their illness 1. The most common primary sites are lung, melanoma,&#xD;
      renal, breast and colorectal cancer 2. Options for patients with brain metastases had been&#xD;
      limited to whole brain radiotherapy (WBRT) or supportive care alone, and systemic&#xD;
      chemotherapy was often discontinued. Historically, the best possible supportive care or&#xD;
      whole-brain radiotherapy (WBRT) were the standard of care 1 aiming at temporary symptom&#xD;
      relief. For WBRT, efficacy in symptom relief but also in prolongation of the median survival&#xD;
      time by 3-6 months is well documented. To date, microsurgical approaches and SRS, both proved&#xD;
      to be safe and efficient, offer alternative treatment options that potentially meet these&#xD;
      concerns 6,7. After proving its efficacy in achieving local tumor control in the treated&#xD;
      volume, SRS was used as a stand-alone treatment option in patients with oligometastases (one&#xD;
      to four metastases) in the brain. There is a rapidly expanding recent body of literature on&#xD;
      outcomes of single-fraction SRS or hypofractionated SRS targeting the resection cavity after&#xD;
      surgical resection of BM. Several retrospective series assessed the efficacy and safety of&#xD;
      postoperative SRS to the resection cavity 9 aiming at an enhanced local tumor control but&#xD;
      also at avoidance of the neurotoxic late effects of WBRT. WBRT followed by SRS of the tumor&#xD;
      bed leads to 1-year local control rates of 70-93 %, which is comparable to results after&#xD;
      surgery followed by WBRT. Median survival was 12-18 months with a 1-year incidence of new&#xD;
      metastases in the brain of 45-60 %.&#xD;
&#xD;
      Trial Objectives: This protocol is primarily aimed at evaluating the safety and toxicity&#xD;
      profile of SRS following neurosurgical resection and compares it to that of WBRT as the&#xD;
      established standard of care. Secondary, the local effect of radiation therapy in patients&#xD;
      with brain metastases will be assessed by measuring time to local and loco-regional&#xD;
      recurrence, local and loco-regional PFS and overall survival at 12 months after treatment.&#xD;
&#xD;
      Patients´Selection: Patients with the diagnosis of brain metastases from solid tumors that&#xD;
      have undergone neurosurgical resection of one brain metastasis will be evaluated and screened&#xD;
      for the protocol. All patients fulfilling the inclusion and exclusion criteria will be&#xD;
      informed about the study and included into the study if they declare informed consent.&#xD;
      Registration for the study must be performed before the start of RT.&#xD;
&#xD;
      Trial Design: The trial will be performed as a single-center two-armed prospective randomized&#xD;
      Phase II study. Patients will be randomized into an experimental arm and a control arm. All&#xD;
      patients will receive post-operative contrast-enhanced cranial MRI imaging and imaging will&#xD;
      be assessed by a radiologist. All available MRI sequences, including SPACE will be taken into&#xD;
      consideration for the definition of treatment target lesions. Patients for whom the&#xD;
      post-operative MRI reveals more than 10 suspect intracranial lesions (all sequences taken&#xD;
      into account) will not be included in the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <phase>Phase 2</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>neurological progression-free survival (PFS)</measure>
    <time_frame>12 months PFS rate</time_frame>
    <description>Neurologic progression-free survival in follow-up imaging is the primary endpoint of the study. The duration is defined as the time interval between the date start of RT and the date of local and loco-regional progression or death, or the date of leaving the study without local and loco-regional progression (e.g., lost to follow up non-local progression) whatever occurs first. Patients not reported local and loco-regional progressive or dead, or lost to follow-up or non-local progressive will be censored at the date of the last follow-up examination where no signs of local and loco-regional progression were observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>12 months survival rate</time_frame>
    <description>Time interval (days) between the date of RT begin and the date of death or date of leaving the study e.g., lost to follow up) whatever occurs first. Patients not reported dead or lost to follow-up will be censored at the date of the last follow-up or the time when last seen alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local PFS</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>lenght of time (days) till local disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QLQ-C30)</measure>
    <time_frame>up to 12 months after treatment</time_frame>
    <description>Units on a Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loco-regional recurrence</measure>
    <time_frame>up to 12 months after treatment</time_frame>
    <description>Time to loco-regional recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (BN20)</measure>
    <time_frame>up to 12 months after treatment</time_frame>
    <description>Units on a Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence</measure>
    <time_frame>up to 12 months after treatment</time_frame>
    <description>Time to local recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loco-regional PFS</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>lenght of time (days) till loco-regional disease progression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Brain Metastases, Adult</condition>
  <arm_group>
    <arm_group_label>Post-operative SRS of resection cavity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-resolution contrast-enhanced post-operative MRI imaging in preparation for Cyberknife SRS. Cyberknife SRS of the resection cavity and all potential additional metastases diagnosed in the treatment planning MRI (up to 10 lesions)&#xD;
Resection cavity:&#xD;
7 x 5 Gy @ 95%-isodose&#xD;
Potential additional brain metastases:&#xD;
20 Gy @ 70%-isodose (lesions &lt; 2 cm max. diameter) 18 Gy @ 70%-isodose (lesions 2 - 3 cm max. diameter) 6 x 5 Gy @ 70%-isodose (lesions &gt; 3 cm max. diameter)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-operative WBRT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Post-operative WBRT will be performed according to the following dose regimen: 10 x 3 Gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>post-operative stereotactic radiosurgery (SRS)</intervention_name>
    <description>For radiosurgery, patients will be immobilized. Treatment planning including the MRI and planning CT should be performed 1 -2 weeks before SRT and treatment finished at latest 3-4 weeks after surgery. Planning should be as close to SRT as possible.&#xD;
Organs at risk such as the brain stem, optic nerves, chiasm and spinal cord will be contoured. The Clinical Target Volume 1 (CTV1) will be defined as the resection cavity based on MRI and CT including T1 contrast enhanced changes around the resection cavity. The Clinical Target Volume 2 (CTV2) will be defined as a 3mm margin added to CTV1 by isotropic expansion and slightly adjusted as deemed appropriated by the experienced contouring physician. The Planning Target Volume (PTV) will be an additional margin of 1mm added to CTV2 by isotropic expansion.&#xD;
Treatment planning will be performed using Accuray's Multiplan or subsequent approved treatment planning systems for Cyberknife.</description>
    <arm_group_label>Post-operative SRS of resection cavity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Whole brain radiotherapy (WBRT)</intervention_name>
    <description>For WBRT, an individual head fixation mask is manufactured for each patient, and treatment planning is performed as virtual simulation or 3D-conformal RT planning based on CT-imaging. The portals include the whole brain with special focus as including the skull base areas and lamina cribrosa. For low infratentorial lesions, the treatment volume may include the whole brain down to the second cervical vertbra.&#xD;
RT will be applied with two portals (e.g. 87°and 273°) using a 6 MeV linear accelerator.&#xD;
For WBRT, a total dose of 30 Gy in 3 Gy fractions will be applied.</description>
    <arm_group_label>Post-operative WBRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed solid cancer&#xD;
&#xD;
          -  MRI confirmed cerebral metastases&#xD;
&#xD;
          -  Neurosurgical resection of one cerebral metastasis&#xD;
&#xD;
          -  age ≥ 18 years of age&#xD;
&#xD;
          -  Karnofsky Performance Score &gt;60&#xD;
&#xD;
          -  for women with childbearing potential, (and men) adequate contraception.&#xD;
&#xD;
          -  ability to understand character and individual consequences of the clinical trial&#xD;
&#xD;
          -  written informed consent (must be available before enrolment in the trial)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of the patients to take part in the study&#xD;
&#xD;
          -  previous radiotherapy to the brain&#xD;
&#xD;
          -  &gt; 10 unresected brain metastases in postoperative MRI&#xD;
&#xD;
          -  Patients who have not yet recovered from acute toxicities of prior therapies&#xD;
&#xD;
          -  known carcinoma &lt; 2 years ago (excluding carcinoma in situ of the cervix, basal cell&#xD;
             carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment&#xD;
             interfering with study therapy&#xD;
&#xD;
          -  pregnant or lactating women&#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>Juergen Debus, Prof. Dr. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of department Radiation Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Radiotherapy, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Tsao MN, Lloyd N, Wong RK, Chow E, Rakovitch E, Laperriere N, Xu W, Sahgal A. Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD003869. doi: 10.1002/14651858.CD003869.pub3.</citation>
    <PMID>22513917</PMID>
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    <citation>Soliman H, Das S, Larson DA, Sahgal A. Stereotactic radiosurgery (SRS) in the modern management of patients with brain metastases. Oncotarget. 2016 Mar 15;7(11):12318-30. doi: 10.18632/oncotarget.7131.</citation>
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    <citation>Gans JH, Raper DM, Shah AH, Bregy A, Heros D, Lally BE, Morcos JJ, Heros RC, Komotar RJ. The role of radiosurgery to the tumor bed after resection of brain metastases. Neurosurgery. 2013 Mar;72(3):317-25; discussion 325-6. doi: 10.1227/NEU.0b013e31827fcd60.</citation>
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  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 13, 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>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Juergen Debus</investigator_full_name>
    <investigator_title>Prof. Dr. Dr. Jürgen Debus</investigator_title>
  </responsible_party>
  <keyword>Brain Metastase</keyword>
  <keyword>Radiation of resection cavity</keyword>
  <keyword>WBRT (whole brain radiotherapy)</keyword>
  <keyword>SRS (stereotactic radiosurgery)</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/NCT03285932
org study id: ESTRON
nct id: NCT03285932
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In advanced cancer disease brain metastases are common, difficult to treat, and are
      associated with a poor prognosis. As new local and systemic therapies are eventually
      resulting in improved survival and quality of life for patients with brain metastases,
      negative neurocognitive effects of radiation therapy are becoming increasingly important as
      well as good loco-regional disease control of brain metastases.

      Concerning treatment, brain metastases remain a major clinical problem and a
      multidisciplinary approach to management should be adopted. Neurosurgical resection with
      postoperative whole brain radiotherapy (WBRT) is one major treatment option in solitary or
      symptomatic brain metastases. Furthermore, WBRT is recommended for multiple brain metastases.
      For a limited number of brain metastases stereotactic radiosurgery (SRS) has been established
      as a highly effective treatment alternative.

      Recently, a new treatment approach combing neurosurgery with postoperative stereotactic
      radiotherapy (SRT) of the resection cavity is emerging. Based on available evidence,
      postoperative SRT of the resection cavity improves local control following surgery, reduces
      the number of patients who require whole brain radiotherapy, and is well tolerated (1).

      This protocol is aimed at primarily evaluating the safety and toxicity profile of SRT to the
      resection cavity following neurosurgical resection combined with SRT of potentially further
      unresected brain metastases, compared to postoperative whole-brain radiotherapy (WBRT).
      Secondary, the local effect of SRT in patients with brain metastases will be assessed by
      measuring time to local recurrence (LR), local and loco-regional progression-free survival
      (PFS).

      Additional systemic treatment will be carried out according to the standards of the National
      Center for Tumor Therapy (NCT).
Scientific Background: Brain metastases (BM) represent a significant healthcare problem. It
      is estimated that 20% to 40% of patients with cancer will develop metastatic cancer to the
      brain during the course of their illness 1. The most common primary sites are lung, melanoma,
      renal, breast and colorectal cancer 2. Options for patients with brain metastases had been
      limited to whole brain radiotherapy (WBRT) or supportive care alone, and systemic
      chemotherapy was often discontinued. Historically, the best possible supportive care or
      whole-brain radiotherapy (WBRT) were the standard of care 1 aiming at temporary symptom
      relief. For WBRT, efficacy in symptom relief but also in prolongation of the median survival
      time by 3-6 months is well documented. To date, microsurgical approaches and SRS, both proved
      to be safe and efficient, offer alternative treatment options that potentially meet these
      concerns 6,7. After proving its efficacy in achieving local tumor control in the treated
      volume, SRS was used as a stand-alone treatment option in patients with oligometastases (one
      to four metastases) in the brain. There is a rapidly expanding recent body of literature on
      outcomes of single-fraction SRS or hypofractionated SRS targeting the resection cavity after
      surgical resection of BM. Several retrospective series assessed the efficacy and safety of
      postoperative SRS to the resection cavity 9 aiming at an enhanced local tumor control but
      also at avoidance of the neurotoxic late effects of WBRT. WBRT followed by SRS of the tumor
      bed leads to 1-year local control rates of 70-93 %, which is comparable to results after
      surgery followed by WBRT. Median survival was 12-18 months with a 1-year incidence of new
      metastases in the brain of 45-60 %.

      Trial Objectives: This protocol is primarily aimed at evaluating the safety and toxicity
      profile of SRS following neurosurgical resection and compares it to that of WBRT as the
      established standard of care. Secondary, the local effect of radiation therapy in patients
      with brain metastases will be assessed by measuring time to local and loco-regional
      recurrence, local and loco-regional PFS and overall survival at 12 months after treatment.

      Patients´Selection: Patients with the diagnosis of brain metastases from solid tumors that
      have undergone neurosurgical resection of one brain metastasis will be evaluated and screened
      for the protocol. All patients fulfilling the inclusion and exclusion criteria will be
      informed about the study and included into the study if they declare informed consent.
      Registration for the study must be performed before the start of RT.

      Trial Design: The trial will be performed as a single-center two-armed prospective randomized
      Phase II study. Patients will be randomized into an experimental arm and a control arm. All
      patients will receive post-operative contrast-enhanced cranial MRI imaging and imaging will
      be assessed by a radiologist. All available MRI sequences, including SPACE will be taken into
      consideration for the definition of treatment target lesions. Patients for whom the
      post-operative MRI reveals more than 10 suspect intracranial lesions (all sequences taken
      into account) will not be included in the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: neurological progression-free survival (PFS)
time frame: 12 months PFS rate
description: Neurologic progression-free survival in follow-up imaging is the primary endpoint of the study. The duration is defined as the time interval between the date start of RT and the date of local and loco-regional progression or death, or the date of leaving the study without local and loco-regional progression (e.g., lost to follow up non-local progression) whatever occurs first. Patients not reported local and loco-regional progressive or dead, or lost to follow-up or non-local progressive will be censored at the date of the last follow-up examination where no signs of local and loco-regional progression were observed.
measure: Overall survival (OS)
time frame: 12 months survival rate
description: Time interval (days) between the date of RT begin and the date of death or date of leaving the study e.g., lost to follow up) whatever occurs first. Patients not reported dead or lost to follow-up will be censored at the date of the last follow-up or the time when last seen alive.
measure: Local PFS
time frame: 12 months after treatment
description: lenght of time (days) till local disease progression
measure: Quality of life (QLQ-C30)
time frame: up to 12 months after treatment
description: Units on a Scale
measure: Loco-regional recurrence
time frame: up to 12 months after treatment
description: Time to loco-regional recurrence
measure: Quality of life (BN20)
time frame: up to 12 months after treatment
description: Units on a Scale
measure: Local recurrence
time frame: up to 12 months after treatment
description: Time to local recurrence
measure: Loco-regional PFS
time frame: 12 months after treatment
description: lenght of time (days) till loco-regional disease progression
arm group label: Post-operative SRS of resection cavity
arm group type: Experimental
description: High-resolution contrast-enhanced post-operative MRI imaging in preparation for Cyberknife SRS. Cyberknife SRS of the resection cavity and all potential additional metastases diagnosed in the treatment planning MRI (up to 10 lesions)
Resection cavity:
7 x 5 Gy @ 95%-isodose
Potential additional brain metastases:
20 Gy @ 70%-isodose (lesions < 2 cm max. diameter) 18 Gy @ 70%-isodose (lesions 2 - 3 cm max. diameter) 6 x 5 Gy @ 70%-isodose (lesions > 3 cm max. diameter)
arm group label: Post-operative WBRT
arm group type: Other
description: Post-operative WBRT will be performed according to the following dose regimen: 10 x 3 Gy
intervention type: Radiation
intervention name: post-operative stereotactic radiosurgery (SRS)
description: For radiosurgery, patients will be immobilized. Treatment planning including the MRI and planning CT should be performed 1 -2 weeks before SRT and treatment finished at latest 3-4 weeks after surgery. Planning should be as close to SRT as possible.
Organs at risk such as the brain stem, optic nerves, chiasm and spinal cord will be contoured. The Clinical Target Volume 1 (CTV1) will be defined as the resection cavity based on MRI and CT including T1 contrast enhanced changes around the resection cavity. The Clinical Target Volume 2 (CTV2) will be defined as a 3mm margin added to CTV1 by isotropic expansion and slightly adjusted as deemed appropriated by the experienced contouring physician. The Planning Target Volume (PTV) will be an additional margin of 1mm added to CTV2 by isotropic expansion.
Treatment planning will be performed using Accuray's Multiplan or subsequent approved treatment planning systems for Cyberknife.
arm group label: Post-operative SRS of resection cavity
intervention type: Radiation
intervention name: Whole brain radiotherapy (WBRT)
description: For WBRT, an individual head fixation mask is manufactured for each patient, and treatment planning is performed as virtual simulation or 3D-conformal RT planning based on CT-imaging. The portals include the whole brain with special focus as including the skull base areas and lamina cribrosa. For low infratentorial lesions, the treatment volume may include the whole brain down to the second cervical vertbra.
RT will be applied with two portals (e.g. 87°and 273°) using a 6 MeV linear accelerator.
For WBRT, a total dose of 30 Gy in 3 Gy fractions will be applied.
arm group label: Post-operative WBRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juergen Debus, Prof. Dr. Dr.
role: Principal Investigator
affiliation: Head of department Radiation Oncology
facility: 
country: Germany
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responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Juergen Debus
investigator title: Prof. Dr. Dr. Jürgen Debus
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
sharing ipd: No