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

  • STATUS
    Recruiting
  • participants needed
    180
  • sponsor
    Universitaire Ziekenhuizen Leuven
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Updated on 16 February 2024
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metastasis
lymphoma
multiple myeloma
stereotactic radiation therapy
brain metastases
karnofsky performance status
carcinoma
cavities
dental caries
germ cell tumor
brain metastasis
stereotactic radiation
contrast-enhanced magnetic resonance imaging
local ablative therapy
small cell lung cancer
neoplasm
MET
magnetic resonance imaging

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

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.

Details
Condition Brain Metastases, Adult
Age 18years - 100years
Treatment Stereotactic Radiotherapy
Clinical Study IdentifierNCT04397978
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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metastasis
lymphoma
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germ cell tumor
brain metastasis
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contrast-enhanced magnetic resonance imaging
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MET
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