Clinical trial NCT04397978: Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
Official title: Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases, Adult
Keywords: Stereotactic radiotherapy
Brain metastases
Multiple (4-10)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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 multiple (4-10) brain metastases

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: From baseline to 3 month after radiotherapy
measure: Quality of life
timeFrame: From baseline to 3 month after radiotherapy
measure: Quality of life
timeFrame: From baseline to 3 month after radiotherapy
Secondary outcomes:
measure: Quality of life
timeFrame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
measure: Quality of life
timeFrame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
measure: Quality of life
timeFrame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
measure: Local control
timeFrame: Time from SRT until local progression or death whichever comes first, up to 3 years after LAT
measure: Survival
timeFrame: Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT
measure: Survival
timeFrame: Time from SRT until death from any cause
measure: Radiotherapy induced toxicity
timeFrame: From baseline to ≤ 90 days after radiotherapy
measure: Radiotherapy induced toxicity
timeFrame: From > 90 days after radiotherapy through study completion
measure: Radiotherapy induced toxicity
timeFrame: Change in toxicity measured from baseline up to 3 years after radiotherapy
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: UZ Leuven
name: Patrick Berkovic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Maarten Lambrecht, PHD
role: STUDY_CHAIR
affiliation: UZ Leuven
name: Eva Oldenburger, MD
role: STUDY_CHAIR
affiliation: UZ Leuven
name: An Nulens
role: STUDY_CHAIR
affiliation: UZ Leuven
name: Lien Smets, BA
role: STUDY_CHAIR
References: