About this trial
Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.
Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.
In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.
Eligibility criteria
Qualifiers
Age ≥ 18 years old
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Female or Male
Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).
Disqualifiers
Pregnant and/or lactating women.
Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.
Trial design
Treatments tested in this trial
- Samples collection: Plasma
- Samples collection: CSF
- Samples collection: Non-CNS Metastatic Tumour Tissue
- Brain MRI
- Samples collection: Serum
Treatment groups
Sponsors and collaborators
Jules Bordet Institute
Lead sponsor
Fondation Cancer, Belgique
Collaborator
Les Amis
Collaborator
Bristol-Myers Squibb
Collaborator
Fondation Cancer, Luxembourg
Collaborator