Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases

Conditions
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Brain Metastases, Adult

Intervention / Treatment
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* Radiation: Stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ≥ 18 years of age 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. Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm Maximal cumulative GTV (+CTV for cavity) of 30cm3 Karnofsky performance status ≥ 70 DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or >3 months respectively. Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded. Ability to provide written informed consent and to participate in the procedure of the questionnaires. Exclusion Criteria: BM not amenable to SRT Previous SRT or surgery on the same lesion Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT Any psychological, sociological or geographical issue potentially hampering compliance with the study Pregnancy Concurrent use of systemic therapy More than 10 BM on planning-MRI Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI A brainstem metastasis with a PTV of more than 20 cm3 Leptomeningeal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Stereotactic radiotherapy|Local ablative therapy with SRT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measured by the EQ-5D-5L questionnaire | From baseline to 3 month after radiotherapy | 
| Quality of life | Measured by the QLQ-BN20 questionnaire | From baseline to 3 month after radiotherapy | 
| Quality of life | Measured by the PRO-CTCAE | From baseline to 3 month after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measured by the EQ-5D-5L questionnaire | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | 
| Quality of life | Measured by the QLQ-BN20 questionnaire | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | 
| Quality of life | Measured by the PRO-CTCAE | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | 
| Local control | Local control of the irradiated metastases | Time from SRT until local progression or death whichever comes first, up to 3 years after LAT | 
| Survival | Brain metastasis free survival | Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT | 
| Survival | Overall survival | Time from SRT until death from any cause | 
| Radiotherapy induced toxicity | Acute toxicity | From baseline to ≤ 90 days after radiotherapy | 
| Radiotherapy induced toxicity | Late toxicity | From > 90 days after radiotherapy through study completion | 
| Radiotherapy induced toxicity | Occurrence of radionecrosis | Change in toxicity measured from baseline up to 3 years after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic radiotherapy, Brain metastases, Multiple (4-10)