Radiotherapy of Multiple Brain Metastases Using AGuIX®

Last updated: June 13, 2024
Sponsor: University Hospital, Grenoble
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasm Metastasis

Cancer

Cancer Treatment

Treatment

Whole Brain Radiation Therapy

AGuIX®

Clinical Study ID

NCT03818386
38RC18.085
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Whole Brain Radiation Therapy
Phase: 2
Study Start date:
March 26, 2019
Estimated Completion Date:
March 26, 2025

Study 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 histologic types. Surgery, stereotactic radiosurgery, radiotherapy and chemotherapy are the main treatments currently proposed.

For patients with multiple brain metastases, whole brain radiation therapy (WBRT) remains the standard of care. However, the median overall survival is less than 6 months and new approaches need to be developed to improve treatment of these patients.

In this context, the weak control of the disease comes from three main factors: the multiplicity of the brain lesions, the radioresistance of certain histologies and the poor distribution of cytotoxic agents in brain metastases.

The use of radiosensitizing agents is here of great interest. The radiosensitizing agent chosen in this study is AGuIX®. It is a Gadolinium-chelated polysiloxane based nanoparticle developed by NH TherAguix company for its theranostic properties (radiosensitization and diagnosis by multimodal imaging). Preclinical studies have demonstrated the radiosensitizing effect of AGuIX® in vivo in 8 tumor models xenografted in rodents, and particularly in brain tumors.

Connect with a study center

  • Institut Régional du Cancer

    Montpellier, Occitanie 34298
    France

    Site Not Available

  • Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie

    Toulouse, Occitanie 31059
    France

    Site Not Available

  • Centre Leon Berard Lyon

    Lyon, Rhones Alpes 69373
    France

    Site Not Available

  • Centre Hospitalier Annecy Genevois

    Annecy, Rhones-Alpes 74374
    France

    Site Not Available

  • Centre Hospitalier Universitaire Grenoble-Alpes

    Grenoble, Rhones-Alpes 38700
    France

    Site Not Available

  • CRLCC - Institut Bergonié

    Bordeau, 33000
    France

    Site Not Available

  • CRLCC - Institut Bergonié

    Bordeaux, 33000
    France

    Site Not Available

  • Crlcc Francois Baclesse

    Caen, 14000
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Centre OSCAR LAMBRET

    Lille, 59000
    France

    Site Not Available

  • Hospices Civils de Lyon-Hôpital Lyon Sud

    Lyon, 69495
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille, 13385
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • La Pitié Salpêtrière - Charles Foix

    Paris, 75651
    France

    Site Not Available

  • Institut Curie Saint Cloud

    Saint-Cloud, 92210
    France

    Site Not Available

  • Crlcc Paul Strauss

    Strasbourg, 67085
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine ALEXIS VAUTRIN

    Vandœuvre-lès-Nancy, 54519
    France

    Site Not Available

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