Radiotherapy of Multiple Brain Metastases Using AGuIX®

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).

The main endpoint will be evaluated by a blinded endpoint committee.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: NH THERAGUIX; NH TherAguix SAS

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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