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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04397978
Other study ID # S63789
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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