Status:
RECRUITING
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Brain Metastases, Adult
Eligibility:
All Genders
18+ years
Brief 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 mu...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04397978
Start Date
October 10 2020
End Date
June 1 2025
Last Update
July 1 2024
Active Locations (1)
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1
UZLeuven
Leuven, Belgium, 3000