Clinical trial

Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.

Name

38RC18.085

Description

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.

Trial arms

Trial start

2019-03-26

Estimated PCD

2024-06-26

Trial end

2025-03-26

Status

Recruiting

Phase

Early phase I

Treatment

AGuIX®

3 intravenous injection at 100mg/kg * D0: AGuIX® injection followed by MRI (within 7 days before commencement of WBRT) * Fr1: AGuIX® injection before the first radiation session * Fr6: AGuIX® injection before the sixth radiation session

Arms:

AGuIX® + Whole Brain Radiation Therapy

Other names:

Gadolinium-chelated polysiloxane based nanoparticles

Whole Brain Radiation Therapy

30 Gy in 10 fractions of 3 Gy over 2-3 weeks

Arms:

AGuIX® + Whole Brain Radiation Therapy, Whole Brain Radiation Therapy

Other names:

WBRT

Size

100

Primary endpoint

Best objective intracranial response rate - intent-to-treat

at 6 weeks

Best objective intracranial response rate - intent-to-treat

at 3 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Randomized Open Blinded Endpoint phase II clinical trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The main endpoint will be evaluated by a blinded endpoint committee.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-08-18

1 organization

1 product

3 indications

Organization

University Hospital of Grenoble

Product

Indication

Indication

Indication