Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00014694

Trial Description

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Title

Stereotactic radiosurgery (SRS) versus whole-brain radiotherapy (WBRT) in patients
with 4-10 brain metastases

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Trial Acronym

STEREOBRAIN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In most cases, whole brain radiotherapy is the therapy of choice when a greater number of brain metastases are diagnosed in a patient. In case of a smaller number (usually up to 3 or 4) of not too large brain metastases, a so-called stereotactic radiosurgery can be performed. Unlike with whole brain radiotherapy, in which the entire brain is irradiated in several therapy sessions (mostly 10), the metastases are irradiated individually in a high dose in a single session with avoiding the healthy tissue. A Japanese research team under Yamamoto suggests that radiosurgery of up to 10 metastases shows just as good results as a radiosurgery of 1-4 metastases. In order to examine this further, this study examines the radio surgery of 4-10 metastases and compares it with previous results of whole brain radiotherapy.

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Brief Summary in Scientific Language

For the majority of patients presenting with multiple (>3-4) brain metastases, WBRT is typically the treatment of choice. The evidence for deferring WBRT is scarse and primarily limited to retrospective data. Concerning SRS to multiple brain metastases, Yamamoto and colleagues (JLGK0901 trial) noted that SRS to up to 10 brain metastases without WBRT seems to be an effective initial treatment option, and is non-inferior to SRS to 2-4 brain metastases in terms of overall survival. Regarding treatment-related adverse-events following SRS to 5-10 brain metastases no significant difference could be noted as compared to the control arm. Overall, the prospective study could yield excellent survival results with low morbidity. Other studies have payed focused attention to the comparison of quality of life, as well as neurocognitive function between the two modalities. According to the excellent results reported by Yamamoto and colleagues we hypothesized that SRS to multiple brain metastases (4-10) could yield increased brain local control as compared to WBRT alone and subsequently improve overall survival. Therefore, a propensity-score matched cohort study is planned with a 2:1 allocation ratio for WBRT vs. SRS. An unselected WBRT group will be used as historical control. SRS patients are prospectively chosen and will be compared by propensity-scored matched analysis (GPA score, histology) to the retrospective WBRT patients.

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Organizational Data

  •   DRKS00014694
  •   2018/05/25
  •   [---]*
  •   yes
  •   Approved
  •   436-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C79.3 -  Secondary malignant neoplasm of brain and cerebral meninges
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Interventions/Observational Groups

  •   Stereotactic Radiosurgery of cerebral metastases (4-10) using the "multiple Brainmets SRS" software from Brainlab®
  •   Retrospective cohort with patients who received whole brain radiotherapy, but would fit into the inclusion criteria of the first arm
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   II
  •   N/A
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Primary Outcome

Overallsurvival

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Secondary Outcome

Intercraniell control; acute and late toxicity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/28
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patient must be able to comply with the study protocol and provide informed consent
- Age ≥18 years, male and female
- Patients with 4-10 brain metastases of any malignancy except lymphoma/germinoma/SCLC
- Brain metastases of 0.4-2.5 cm extent
- GPA scores 0-3

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Exclusion Criteria

- Patients without legal capacity or unable to understand the nature, significance and consequences of the study
- Simultaneous participation in other interventional trials which could interfere with this trial and/or participation before the end of a required restriction period
- Pregnancy
- Cerebral lymphomas or metastases of germinoma or SCLC
- Meningiosis carcinomatosa
- Previous whole brain irradiation
- Inability to undergo an MRI examination (e. g. pacemaker)

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.