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

Brain Metastases, Adult Clinical Trial

— LAT-MUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04397978
• Other study ID #: S63789
• Status: Recruiting
• Start date: October 10, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Patrick Berkovic, MD
• Phone: +32-16-34-76-00
• Email: Patrick.berkovic[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Stereotactic radiotherapy
Local ablative therapy with SRT

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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