Spots Global Cancer Trial Database for AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma
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Trial Identification
Brief Title: AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma
Official Title: Phase I/II Study of AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma
Study ID: NCT04881032
Conditions
Study Description
Brief Summary: This is a phase I/II clinical trial evaluating the association of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma. The primary objectives of this study were to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period (phase I) and to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate (PFS) (phase II) Three dose levels of intravenous AGuIX nanoparticles will be explored: 50 mg/kg, 75 mg/kg and 100 mg/kg.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU de Brest, Brest, , France
Centre Jean Perrin, Clermont-Ferrand, , France
CHU de Grenoble, Grenoble, , France
Centre Léon Berard, Lyon, , France
Hospices Civils de Lyon, Lyon, , France
Hôpital La Pitié Salpetrière, Paris, , France
Institut de Cancérologie de l'Ouest, Saint Herblain, , France
Institut de Cancérologie Strasbourg Europe, Strasbourg, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Juliette Moreau, Md
Affiliation: Centre Jean Perrin
Role: PRINCIPAL_INVESTIGATOR
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