AGuIX Nanoparticles with Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

Inclusion Criteria:

• Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery)

• Patient not operated or partial resection

• KPS superior to 70%

• Age between 18 years old and 75 years old

• Life expectancy superior to 6 months

• Platelets superior to 100,000 / mm3

• PNN superior to 1500 / mm3

• Hb superior to 10 g / dL

• Creatinine superior to 1.5 times the upper normal limit or clearance according toCockcroft-Gault superior to 50 mL / min

• Liver function (GGT, PAL, ASAT, ALAT, bilirubin) superior to 1.5 times the uppernormal limit

• For patients receiving treatment with corticosteroids, treatment withcorticosteroids must be at a stable or decreasing dose for at least 14 days beforeinclusion

• Patient able to swallow and retain oral medication

• Negative serum pregnancy test within 7 days before the first administration oftreatment for women

• Women of childbearing potential and men whose partners are of childbearing potentialmust agree to use, themselves or their partners, an approved method of contraceptionthroughout the treatment and at least 6 months after the last administration ofstudy treatment.

• Obtaining signed informed consent from the patient

• Patient affiliated to a social security regimen

Exclusion Criteria:

• prior brain radiotherapy

• prior chemotherapy (including implants containing carmustine (Gliadel®) orimmunotherapy (vaccination included)

• Any contraindication to TMZ listed in the SPCs

• History of major intestinal resection which may modify the absorption of oral drugsaccording to the judgment of the investigator

• Diagnosed inflammatory bowel disease (Crohn disease or ulcerative colitis)

• Diarrhea superior to grade 2 CTCAE (whatever the cause)

• Current or recent treatment with another investigational drug or participation inanother therapeutic clinical trial (within 30 days of inclusion).

• History of other cancer in the 5 years preceding inclusion, except for basal cellcarcinomas of the skin and in situ carcinomas of the cervix

• Pregnant or breastfeeding women

• Contraindication to MRI or gadolinium injection

• History of severe anaphylactic reactions due to the injection of gadolinium-basedcontrast product (dotarem, etc.)

• Patient under guardianship or curatorship

• History of nephropathy

• Psychological disorder or social or geographic reasons that may compromise medicalmonitoring of the trial or compliance with treatment