Brain Metastases, AdultLAT-MUMNCT04397978
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
An observational study of Brain Metastases, Adult, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- Stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2020to 1 Jun 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven
Leuven, 3000
Patrick Berkovic, MD
Maarten Lambrecht, MD, PhD
About this study
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
Read the 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.
- Conditions
- Brain Metastases, Adult
- Being tested
- Stereotactic radiotherapy
- Keywords
- Stereotactic radiotherapy, Brain metastases, Multiple (4-10)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapyRadiation
Also called SRT
Local ablative therapy with SRT
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured by the EQ-5D-5L questionnaire
Measured: From baseline to 3 month after radiotherapy
Quality of life
Measured by the QLQ-BN20 questionnaire
Measured: From baseline to 3 month after radiotherapy
Quality of life
Measured by the PRO-CTCAE
Measured: From baseline to 3 month after radiotherapy
Secondary outcomes (9)
Quality of life
Measured by the EQ-5D-5L questionnaire
Measured: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life
Measured by the QLQ-BN20 questionnaire
Measured: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life
Measured by the PRO-CTCAE
Measured: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Local control
Local control of the irradiated metastases
Measured: Time from SRT until local progression or death whichever comes first, up to 3 years after LAT
Survival
Brain metastasis free survival
Measured: Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT
Survival
Overall survival
Measured: Time from SRT until death from any cause
Radiotherapy induced toxicity
Acute toxicity
Measured: From baseline to ≤ 90 days after radiotherapy
Radiotherapy induced toxicity
Late toxicity
Measured: From > 90 days after radiotherapy through study completion
Radiotherapy induced toxicity
Occurrence of radionecrosis
Measured: Change in toxicity measured from baseline up to 3 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start10 Oct 2020
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Berkovic, MD, Principal investigator, UZ LeuvenMaarten Lambrecht, PHD, Study chair, UZ LeuvenEva Oldenburger, MD, Study chair, UZ LeuvenAn Nulens, Study chair, UZ LeuvenLien Smets, BA, Study chair, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397978
- Sponsor's protocol ID
- S63789
- Acronym
- LAT-MUM
- Status last verified
- Jun 2024
- First submitted
- 11 May 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
- ClinicalTrials.gov ID
- NCT04397978
- Acronym / sponsor ID
- LAT-MUM / S63789
- Conditions
- Brain Metastases, Adult
- Keywords
- Stereotactic radiotherapy, Brain metastases, Multiple (4-10)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiotherapyAlso: SRTLocal ablative therapy with SRT | Radiation | – |
Primary outcome
Quality of life
Time frame: From baseline to 3 month after radiotherapy
Measured by the EQ-5D-5L questionnaire
Quality of life
Time frame: From baseline to 3 month after radiotherapy
Measured by the QLQ-BN20 questionnaire
Quality of life
Time frame: From baseline to 3 month after radiotherapy
Measured by the PRO-CTCAE
9 secondary outcomes
Quality of life
Time frame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life
Time frame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Quality of life
Time frame: From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy
Local control
Time frame: Time from SRT until local progression or death whichever comes first, up to 3 years after LAT
Survival
Time frame: Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT
Survival
Time frame: Time from SRT until death from any cause
Radiotherapy induced toxicity
Time frame: From baseline to ≤ 90 days after radiotherapy
Radiotherapy induced toxicity
Time frame: From > 90 days after radiotherapy through study completion
Radiotherapy induced toxicity
Time frame: Change in toxicity measured from baseline up to 3 years after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Berkovic, MD principal investigator
UZ Leuven
Maarten Lambrecht, PHD study chair
UZ Leuven
Eva Oldenburger, MD study chair
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, Adult, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Berkovic, MD (+32-16-34-76-00, Patrick.berkovic@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: From baseline to 3 month after radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.