About this trial
The research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Age ≥18
Karnofsky performance status ≥60
Disqualifiers
Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
More than 4 brain metastases or the diameter of the metastasis for resection >4.0 cm.
More than 1 metastasis requiring resection
Trial design
Parallel
Treatments tested in this trial
preoperative radiosurgery
Radiationsingle fraction radiosurgery
postoperative hypofractionated stereotactic radiotherapy
Radiationfractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care
Treatment groups
Trial outcomes
Primary outcomes
Leptomeningeal disease
time to leptomeningeal disease
Secondary outcomes
Local control of the surgical cavity
No evidence of tumour recurrence on contrast-enhanced MRI
Distant brain failure
New brain metastases
Radionecrosis
Adverse radiation effects
Quality of life assessment
EORTC questionnaire core questionnaire QLQ30, EORTC questionnaire brain module BN 20 (1-4, low scores reflect better QoL)
Sponsors and contacts
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