Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial.
- Conditions
- Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRTMedDRA version: 20.0Level: LLTClassification code 10006128Term: Brain metastasesSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001879-20-FR
- Lead Sponsor
- Grenoble Alps University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
-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) performans 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
- No renal insufficiency
(glomerular filtration rate = 50 mL/min/1.73m²)
- Affiliated to a social security regimen
- Effective methods of contraception must be used throughout the study .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
-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
-Inclusion in another clinical trial protocol
-Pregnancy or breastfeeding
-Subject in exclusion period of another study
-Subject under administrative or judicial control
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method