About this trial
Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
At least one brain metastasis of large cell cancer suitable for SRT
Karnofsky Performance Status ≥ 70
Ability to provide written informed consent
Disqualifiers
Contra-indication for MRI scan
Primary tumor of small cell lung cancer, germinoma or lymphoma
Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation)
Presence of leptomeningeal metastases
Trial design
Parallel
Treatments tested in this trial
SRT
RadiationSRT
fSRT
RadiationfSRT
Treatment groups
Trial outcomes
Primary outcomes
radio necrosis or local failure
Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).
Secondary outcomes
Survival
median survival with Kaplan Meyer analysis
symptomatic radio necrosis (RN) or local failure (LF)
incidence of RN or LF within 2 years after SRT
salvage treatment
incidence of salvage treatment within 2 years after SRT
distant brain recurrences
incidence of distant brain recurrences within 2 years after SRT
Sponsors and contacts
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