Brain Metastases, Adult Clinical Trial
— LAT-MUMOfficial title:
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
NCT number | NCT04397978 |
Other study ID # | S63789 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 10, 2020 |
Est. completion date | June 1, 2023 |
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
Status | Recruiting |
Enrollment | 180 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZLeuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life | Measured by the EQ-5D-5L questionnaire | From baseline to 3 month after radiotherapy | |
Primary | Quality of life | Measured by the QLQ-BN20 questionnaire | From baseline to 3 month after radiotherapy | |
Primary | Quality of life | Measured by the PRO-CTCAE | From baseline to 3 month after radiotherapy | |
Secondary | Quality of life | Measured by the EQ-5D-5L questionnaire | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | |
Secondary | Quality of life | Measured by the QLQ-BN20 questionnaire | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | |
Secondary | Quality of life | Measured by the PRO-CTCAE | From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Survival | Overall survival | Time from SRT until death from any cause | |
Secondary | Radiotherapy induced toxicity | Acute toxicity | From baseline to = 90 days after radiotherapy | |
Secondary | Radiotherapy induced toxicity | Late toxicity | From > 90 days after radiotherapy through study completion | |
Secondary | Radiotherapy induced toxicity | Occurrence of radionecrosis | Change in toxicity measured from baseline up to 3 years after radiotherapy |
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