C79.3
Conditions
Interventions
Group 1: Stereotactic radiosurgery or stereotactic fractionated radiotherapy of multiple (4-10) brain metastases
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patient's written informed consent has been obtained 2. Age 18-80 years, male or female 3. Legal capacity, patient is able to understand the nature, significance, and consequences of the trial 4. At least 4 brain metastases of solid tumours, with at least one and not exceeding 10 metastases = 3 mm (i.e. eligible for SRS/SFRT) 5. RPA classification I or II
Exclusion criteria
Exclusion criteria: 1. Simultaneous participation in other interventional trials which could interfere with this trial 2. Participation in an interventional clinical trial within the last thirty days before the start of this trial, previous participation in this trial 3. Known or persistent abuse of medication, drugs or alcohol 4. Persons who are in a relationship of dependence/employment with the sponsor or the investigator 5. Pregnancy, nursing or patient not willing to prevent a pregnancy during treatment 6. Cerebral lymphomas, metastases of germ cell tumours, small cell lung carcinoma 7. Metastases (either preirradiated or not) or resection cavity within the hippocampus or in a distance of 7 mm to the hippocampus 8. Acute neurological symptoms demanding an immediate start of RT 9. CNS diseases or syndromes accompanied by cognitive deficits or radiological changes of the brain, e.g., dementia, major depression, clinically manifest hypertensive encephalopathy, meningiosis carcinomatosa 10. Previous brain irradiation (SRS/SFRT) of >1 brain metastasis >3cm or >3 brain metastases >1cm each 11. Previous brain irradiation 1 brain metastasis (biopsy allowed) 13. Previous surgical resection of 1 brain metastasis 1 brainstem metastasis =3mm 18. Brainstem metastasis >2cm 19. Brain metastasis >3.5cm 20. Resection cavity eligible for dose escalation >3.5cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognitive function, measured by the difference between verbal learning performance at three months after radiation therapy and at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Intracranial progression (local tumour progression, distant tumour progression, progression within hippocampus, number of new cerebral metastases) • Extracranial progression • Overall survival • Death caused by brain metastases • Locally progression-free survival • Progression-free survival • Changes in other cognitive performance measures • Depression • Health-related and individual quality of life • Morphological alterations on MRI • Biomarkers of response as determined in blood samples | — |
Countries
Germany
Contacts
Public ContactAnca-L. Grosu
Universitätsklinikum Freiburg
Outcome results
None listed