Trial document





This trial has been registered retrospectively.
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  DRKS00003862

Trial Description

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Title

Monocentre evaluation of morphological and neurocognitive alterations after whole brain radiotherapy using IMRT technique with hippocampal sparing and boost to the metastases

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Trial Acronym

Hipporad-mono

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Whole brain radiotherapy (WBRT) is a common treatment for multiple brain metastases. Besides positive effects, WBRT may exert neurotoxic effects on memory-relevant brain structures and impair memory capabilities. Sparing of the hippocampus region, which is crucial for memory functions, during WBRT has recently become feasible. This study aims to test if patients treated with WBRT and hippocampal sparing benefit from this treatment, compared to historic controls treated without hippocampal sparing. Volumes of the hippocampus, memory performance, and quality of life, among others, will be assessed.

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Brief Summary in Scientific Language

Whole brain radiotherapy (WBRT) is a common treatment for multiple brain metastases. Besides the positive effects of tumor control, WBRT may exert neurotoxic effects on the memory-relevant hippocampal brain region and impair memory capabilities and quality of life. The hippocampal region contains neuronal stem cells that maintain lifelong neurogenesis. Memory disorders after WBRT are supposed to be connected to an impaired neurogenesis. Sparing of the hippocampus during WBRT is expected to minimize neurocognitive deficits. Furthermore, several studies have shown that a local increase in radiation dose on distinct metastases can improve local control of these lesions, leading to a longer survival. Current irradiation techniques offer the possibility of sparing the hippocampal region while simultaneously escalating the radiation dose on existing metastases. This study aims at testing whether patients treated with WBRT and hippocampal sparing benefit from this treatment, compared to historic controls treated with WBRT without hippocampal sparing.
Cognitive performance measures, local control, quality of life, and prevention of hippocampal atrophy will be assessed prior to and 3 months after WBRT.

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Organizational Data

  •   DRKS00003862
  •   2016/02/18
  •   [---]*
  •   yes
  •   Approved
  •   236/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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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

  •   Whole-brain radiotherapy with hippocampal sparing and dose escalation to metastases
  •   Historic controls treated without hippocampal sparing
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   N/A
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Primary Outcome

Hippocampal volume change (based on MRI) 3 months after therapy

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Secondary Outcome

Change of memory performance (verbal learning) and quality of life, survival, local tumor control

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/22
  •   70
  •   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

Patients with 4-8 brain metastases of solid tumors with indication for WBRT
Metastases of 5 - 35mm width
RPA classification I and II
Written informed consent

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Exclusion Criteria

Cerebral lymphoma, metastases from germ cell tumors or SLCL
RPA classification III
lack of MRI tolerance
acute neurologic symptoms demanding immediate therapy
accompanying diseases with possible cognitive symptoms or white matter change
antiepileptic medication: benzodiazepine, barbiturate, topiramat, hydantoine, valproic acid, carbamazepin
demetia, depression, diabetes mellitus
hypertensive encephalopathy
metastases within the hippocampus or with 10mm range

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Strahlenheilkunde, Freiburg
    • Ms.  Prof. Dr. med.  A.-L.  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Anca-Ligia  Grosu 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde Universitätsklinikum Freiburg
    • Mr.  Dr.  Oliver  Oehlke 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Strahlenheilkunde Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Anca-Ligia  Grosu 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    •   0761-270-94610
    •   0761-270-94720
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/31
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Trial Publications, Results and other Documents

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