Brain Metastases, Adult
Conditions
Keywords
Stereotactic radiotherapy, Brain metastases, Multiple (4-10)
Brief summary
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
Detailed description
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.
Interventions
RADIATIONStereotactic radiotherapy
Local ablative therapy with SRT
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, ≥ 18 years of age 2. Minimal 4 and up to a maximum of 10 synchronous BM diagnosed on a high resolution contrast-enhanced MRI scan (T1 gadolinium) not dated more than 4 weeks prior to inclusion. 3. Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm 4. Maximal cumulative GTV (+CTV for cavity) of 30cm3 5. Karnofsky performance status ≥ 70 6. DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or \>3 months respectively. 7. Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded. 8. Ability to provide written informed consent and to participate in the procedure of the questionnaires.
Exclusion criteria
1. BM not amenable to SRT 2. Previous SRT or surgery on the same lesion 3. Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT 4. Any psychological, sociological or geographical issue potentially hampering compliance with the study 5. Pregnancy 6. Concurrent use of systemic therapy 7. More than 10 BM on planning-MRI 8. Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI 9. A brainstem metastasis with a PTV of more than 20 cm3 10. Leptomeningeal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | From baseline to 3 month after radiotherapy | Measured by the EQ-5D-5L questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | Measured by the EQ-5D-5L questionnaire |
| Local control | Time from SRT until local progression or death whichever comes first, up to 3 years after LAT | Local control of the irradiated metastases |
| Survival | Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT | Brain metastasis free survival |
| Radiotherapy induced toxicity | From baseline to ≤ 90 days after radiotherapy | Acute toxicity |
Countries
Belgium
Contacts
Primary ContactPatrick Berkovic, MD
Backup ContactDeveny Vanrusselt, BA
Outcome results
None listed