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

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

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases, Adult
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Patrick Berkovic, MD; Phone Number: +32-16-34-76-00; Email: Patrick.berkovic@uzleuven.be
• Study Contact Backup: Name: Deveny Vanrusselt, BA; Phone Number: +32-16-34-76-00; Email: deveny.vanrusselt@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZLeuven
    • Principal Investigator: Patrick Berkovic, MD
    • Sub-Investigator: Maarten Lambrecht, MD, PhD
    • Sub-Investigator: Eva Oldenburger, MD
    • Sub-Investigator: An Nulens, MA
    • Sub-Investigator: Lien Smets, RN
    • Sub-Investigator: Deveny Vanrusselt, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Measured by the EQ-5D-5L questionnaire	From baseline to 3 month after radiotherapy
Quality of life	Measured by the QLQ-BN20 questionnaire	From baseline to 3 month after radiotherapy
Quality of life	Measured by the PRO-CTCAE	From baseline to 3 month after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Measured by the EQ-5D-5L questionnaire	From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life	Measured by the QLQ-BN20 questionnaire	From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life	Measured by the PRO-CTCAE	From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
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
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
Survival	Overall survival	Time from SRT until death from any cause
Radiotherapy induced toxicity	Acute toxicity	From baseline to ≤ 90 days after radiotherapy
Radiotherapy induced toxicity	Late toxicity	From > 90 days after radiotherapy through study completion
Radiotherapy induced toxicity	Occurrence of radionecrosis	Change in toxicity measured from baseline up to 3 years after radiotherapy

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Patrick Berkovic, MD, UZ Leuven; Study Chair: Maarten Lambrecht, PHD, UZ Leuven; Study Chair: Eva Oldenburger, MD, UZ Leuven; Study Chair: An Nulens, UZ Leuven; Study Chair: Lien Smets, BA, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Stereotactic radiotherapy; Brain metastases; Multiple (4-10)
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: S63789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No