To observe the quality of life (QOL) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (LAT) i.e. stereotactic radiotherapy (SRT) for patients with multiple (4-10) brain metastases
Phase IV prospective non-randomized observational trial (registry trial) for patients with a DS-GPA \> 1.5 or an estimated life expectancy of \>3 months and an established diagnosis on dedicated brain MRI of 4-10 BM of any solid primary tumor. We plan to deliver a local ablative therapy (LAT) i.e. SRT in 1 to 5 fractions on visible BM and post-surgical cavities if applicable. Our primary aim is to provide quality of life (QOL) data and our secondary aim is to report on several toxicity and outcome parameters for this patient cohort.
Study Type
OBSERVATIONAL
Enrollment
180
Local ablative therapy with SRT
UZLeuven
Leuven, Belgium
RECRUITINGQuality of life
Measured by the EQ-5D-5L questionnaire
Time frame: From baseline to 3 month after radiotherapy
Quality of life
Measured by the QLQ-BN20 questionnaire
Time frame: From baseline to 3 month after radiotherapy
Quality of life
Measured by the PRO-CTCAE
Time frame: From baseline to 3 month after radiotherapy
Quality of life
Measured by the EQ-5D-5L questionnaire
Time frame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life
Measured by the QLQ-BN20 questionnaire
Time frame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life
Measured by the PRO-CTCAE
Time frame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Local control
Local control of the irradiated metastases
Time frame: Time from SRT until local progression or death whichever comes first, up to 3 years after LAT
Survival
Brain metastasis free survival
Time frame: Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT
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Survival
Overall survival
Time frame: Time from SRT until death from any cause
Radiotherapy induced toxicity
Acute toxicity
Time frame: From baseline to ≤ 90 days after radiotherapy
Radiotherapy induced toxicity
Late toxicity
Time frame: From > 90 days after radiotherapy through study completion
Radiotherapy induced toxicity
Occurrence of radionecrosis
Time frame: Change in toxicity measured from baseline up to 3 years after radiotherapy