Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life. Therapy options for multiple brain metastases may vary and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (\>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.
In the present multicenter study, the benefit of SRS compared to conventional whole brain radiotherapy, each combined with best supportive care or best supportive care only, in patients with 4-15 brain metastases is to be prospectively investigated. The effect will be measured using quality-adjusted life-years (QUALY). Quality of life and overall survival are therefore primary endpoints. Secondary endpoints are the ability to perform basic activities of daily life (Barthel (ADL) index), progression-free survival, local and locoregional progression-free survival, extracranial progression, toxicity and its treatment, the recording of postherapeutic radiation-induced brain lesions (RIBL), long-term cognitive function, a possible salvage therapy as well as death from brain metastases. Furthermore, die CyberChallenge trial is linked to a translational program via BUB2 study. The BUB2 study conducts biobanking of blood, urine and resection or biopsy material, if available, as well as collects imaging material. This is to find diagnostic and prognostic biomarkers in our cancer patients via analyzing genetic, epigenetic and protein expression patterns as well as radiomics and correlating them to clinical data and therefore further push individualized patient care in brain metastases forward.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Stereotactic Radiotherapy (SRS)
Whole Brain Radiotherapy (WBRT)
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany
RECRUITINGoverall survival
number of alive patients
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
quality of life according to QLQ-C15 (questionaire for patients with advanced cancer referred for palliative radiotherapy
changes in QLQ-C15 scores, scale is 1-100 points, 100 points representing maximum score
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
quality of life according to BN-20 (questionaire for patients with brain neoplasm)
changes in BN-20 scores, scale is 1-100 points, 100 points representing maximum score
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
functional independence assessed by the Barthel ADL index
Changes in Barthel ADL index scores, scale 0-100 points
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
long-term cognitive Status (Hopkins Verbal Learning Test HVLT)
Changes in HVLT scores (minimum 0, maximum 12)
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
development of radiation-induced brain lesions
changes in amounts of Radiation-induced brain lesions
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Radiation induced sideeffects
changes in toxicity rates according to CTCAE 5.0
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Overall survival
amount of alive randomized patients enrolled in the trial
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
local progression of treated metastases
detectable progressive disease of treated metastases
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of leptomeningeal disease
occurrence of leptomeningeal disease
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of treated BM disease
recurrence of treated BM disease
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of new BM disease
occurrence of new BM disease
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Brain salvage during follow-up
medical idication for whole brain Radiation after inital stereotactic radiotherapy
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
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