Experimental: AGuIX + chemoradiotherapy (radiotherapy + temozolomide)
addition of AGuIX nanoparticles to standard radiotherapy and concomitant treatment by temozolomide (TMZ) for patients of phase I and patients randomized in experimental arm of phase II
Sham Comparator: chemoradiotherapy (radiotherapy + temozolomide)
standard of care : chemoradiotherapy (radiotherapy + temozolomide) for patients randomized in control arm of phase II
Drug: - Polysiloxane Gd-Chelates based nanoparticles (AGuIX)
Four intravenous injections of AGuIX will be delivered. Phase I : Three dose levels may be explored 50 mg/kg, 75 mg/kg and 100 mg/ kg. Phase II : recommended dose
Radiation: - radiotherapy
60 Gy in 6 weeks
Drug: - Temozolomide
Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy.
After a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days .