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

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04397978
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitaire Ziekenhuizen KU Leuven
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Patrick Berkovic, MDMaarten Lambrecht, PHDEva Oldenburger, MDAn NulensLien Smets, BA
Principal Investigator Affiliation	UZ LeuvenUZ LeuvenUZ LeuvenUZ LeuvenUZ Leuven
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Adult

Additional Details

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.

Contact a Trial Team

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