Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
ConditionBrain Metastases, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Stereotactic radiotherapy
RadiationLocal ablative therapy with SRT
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Quality of life
Measured by the EQ-5D-5L questionnaire
Time frame
From baseline to 3 month after radiotherapy2
Quality of life
Measured by the QLQ-BN20 questionnaire
Time frame
From baseline to 3 month after radiotherapy3
Quality of life
Measured by the PRO-CTCAE
Time frame
From baseline to 3 month after radiotherapySecondary outcomes
1
Quality of life
Measured by the EQ-5D-5L questionnaire
Time frame
From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy2
Quality of life
Measured by the QLQ-BN20 questionnaire
Time frame
From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy3
Quality of life
Measured by the PRO-CTCAE
Time frame
From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy4
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 LATSponsors and contacts
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Source ClinicalTrials.gov