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

Recruiting

• Conditions: Brain Metastases, Adult

• Registration Number: NCT04397978
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Study Start: 2020-10-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life	From baseline to 3 month after radiotherapy	Measured by the PRO-CTCAE

Secondary Outcome Measures

Name	Time	Method
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
Radiotherapy induced toxicity	Change in toxicity measured from baseline up to 3 years after radiotherapy	Occurrence of radionecrosis
Quality of life	From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy	Measured by the PRO-CTCAE
Survival	Time from SRT until death from any cause	Overall survival

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium