Multicenter, double-blind, placebo-controlled, randomized trial.
Patients affected by STAT3 positive newly diagnosed glioblastoma will be eligible. Patients are randomized using a stratified block randomization method with a 1:1 ratio in two arms:
• Experimental/Control arm: Concomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg/mq + silibinin/placebo 2 sachets/day dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg/m2-200mg/m2, g1-5 q28d + silibinin/placebo 2 sachets/day dissolved in water, day 1-28, q28d for 6-12 cycles. Silibinin/Placebo may be continued until disease progression at the discretion of the physician.
Patients will be stratified based on:
* Type of surgery (complete Vs partial) * MGMT methylation status (methylated Vs non-methylated) * ECOG PS (0-1 Vs 2)
New histologically confirmed diagnosis of glioblastoma (WHO 2021)
Local availability of MGMT methylation status
Immunohistochemical positivity of activated STAT3 (pSTAT3) expression on the tumor tissue sample. STAT3 expression will be evaluated centrally by UOC Anatomia Patologica of Azienda Ospedale Università di Padova.
Chemoradiotherapy start within 7 weeks from surgery
Patients diagnosed with glioblastoma (WHO grade IV 2021) who have only had a diagnostic biopsy
Chemotherapy, immunotherapy, or antineoplastic therapy for glioblastoma
Negative immunohistochemistry of STAT3 expression on the tumor tissue sample
Diagnosis of another tumor or secondary brain localization