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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT04397978

Collaborator

(none)

180

Enrollment

Location

31.7

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Brain Metastases, Adult	Radiation: Stereotactic radiotherapy

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 10, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

Quality of life [From baseline to 3 month after radiotherapy]
Measured by the EQ-5D-5L questionnaire
Quality of life [From baseline to 3 month after radiotherapy]
Measured by the QLQ-BN20 questionnaire
Quality of life [From baseline to 3 month after radiotherapy]
Measured by the PRO-CTCAE

Secondary Outcome Measures

Quality of life [From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy]
Measured by the EQ-5D-5L questionnaire
Quality of life [From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy]
Measured by the QLQ-BN20 questionnaire
Quality of life [From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy]
Measured by the PRO-CTCAE
Local control [Time from SRT until local progression or death whichever comes first, up to 3 years after LAT]
Local control of the irradiated metastases
Survival [Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT]
Brain metastasis free survival
Survival [Time from SRT until death from any cause]
Overall survival
Radiotherapy induced toxicity [From baseline to ≤ 90 days after radiotherapy]
Acute toxicity
Radiotherapy induced toxicity [From > 90 days after radiotherapy through study completion]
Late toxicity
Radiotherapy induced toxicity [Change in toxicity measured from baseline up to 3 years after radiotherapy]
Occurrence of radionecrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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