Status:
UNKNOWN
Radiotherapy of Multiple Brain Metastases Using AGuIX®
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
NH TherAguix SAS
Conditions:
Brain Metastases, Adult
Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT...
Detailed Description
The occurrence of brain metastases is a common event in the history of cancer and negatively affects the life expectancy of patients. Their incidence varies between 15 and 50% according to the histolo...
Eligibility Criteria
Inclusion
- Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRT
- At least 18 years old
- Signed informed consent after informing the patient
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Extracranial disease:
- Complete or partial response or stability under systemic treatment
- No extracranial disease
- Or first line of treatment
- Life expectancy greater than 6 weeks
- Effective contraceptive method for all patient of childbearing potential
- Affiliated to a social security regimen
Exclusion
- Leptomeningeal metastasis
- Evidence of metastasis with recent large hemorrhage
- Progressive and threatening extracranial disease under systemic treatment
- Previous cranial irradiation (except stereotactic irradiation)
- Known contra-indication, sensitivity or allergy to gadolinium
- Known contra-indication for Magnetic Resonance Imaging
- Renal insufficiency (glomerular filtration rate ≤ 50 mL/min/1.73m²)
- Pregnancy or breastfeeding
- Subject under administrative or judicial control
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 26 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03818386
Start Date
March 26 2019
End Date
March 26 2025
Last Update
June 14 2024
Active Locations (14)
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1
Institut Régional du Cancer
Montpellier, Occitanie, France, 34298
2
Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie
Toulouse, Occitanie, France, 31059
3
Centre Leon Berard Lyon
Lyon, Rhones Alpes, France, 69373
4
Centre Hospitalier Annecy Genevois
Annecy, Rhones-Alpes, France, 74374