Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients
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)
Gender: All
Ages: 18 Years - 99 Years
Glioblastoma
IDH Wild-type and STAT3-positive Glioblastoma