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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiotherapy | Radiation | Local ablative therapy with SRT |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with an established diagnosis on dedicated brain magnetic resonance (MRI) of 4-10 brain metastases (BM) of any solid tumor with an estimated life expectancy of >3 months or a disease specific grade prognostic index (DS-GPA) of ≥ 1.5.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Berkovic, MD | Contact | +32-16-34-76-00 | Patrick.berkovic@uzleuven.be | |
| Deveny Vanrusselt, BA | Contact | +32-16-34-76-00 | deveny.vanrusselt@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Berkovic, MD | UZ Leuven | Principal Investigator |
| Maarten Lambrecht, PHD | UZ Leuven | Study Chair |
| Eva Oldenburger, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 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 |
| UZ Leuven |
| Study Chair |
| An Nulens | UZ Leuven | Study Chair |
| Lien Smets, BA | UZ Leuven | Study Chair |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |