Status:
RECRUITING
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
Fondation Cancer, Belgique
Les Amis
Conditions:
CNS Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 de...
Eligibility Criteria
Inclusion
- 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).
- Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program
- Seven cohorts of subjects are defined in this prospective multicenter study:
- Cohort 1: Triple negative breast cancer (TNBC)
- Cohort 2: HER 2 positive breast cancer (HER2+ BC)
- Cohort 3: Non-small cell lung cancer (NSCLC)
- Cohort 4: Small cell lung cancer (SCLC)
- Cohort 5: Melanoma
- Cohort 6: Other solid tumours (apart from the above mentioned subtypes
- Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis
- Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.
- Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
- Predicted life expectancy \> 3 months.
- Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
- Effective contraception is in place for women of childbearing potential
- Completion of all necessary screening procedures within 28 days prior to enrolment.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Inclusion criterion applicable to FRANCE only
- Affiliated to the French Social Security System
Exclusion
- 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.
- Exclusion criterion applicable to FRANCE only
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04109131
Start Date
July 1 2020
End Date
January 1 2029
Last Update
January 6 2026
Active Locations (17)
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1
Institut Jules Bordet
Anderlecht, Belgium, 1070
2
Hôpital Erasme
Brussels, Belgium, 1070
3
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
4
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000