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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04881032
Study type Interventional
Source Centre Jean Perrin
Contact Emilie Thivat
Phone 0473278089
Email emilie.THIVAT@clermont.unicancer.fr
Status Recruiting
Phase Phase 1/Phase 2
Start date March 7, 2022
Completion date March 2027

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