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Study identifier: NCT06964815 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients

Condition: Glioblastoma · IDH Wild-type and STAT3-positive Glioblastoma  ·  Sponsor: Istituto Oncologico Veneto IRCCS

PhaseNA
Planned participants110
Who can joinAll sexes, 18 Years to 99 Years
Healthy volunteersNo

About this study

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)

This description comes directly from the study's public registry record.

Talk to the study team

Giuseppe Lombardi, MD  ·  0498215888  ·  giuseppe.lombardi@iov.veneto.it

Always discuss trial participation with your own doctor first.

Locations (16)

IRCCS Istituto delle Scienze Neurologiche di BolognaBologna, BO, ItalyNot Yet Recruiting
IRST Dino AmadoriMeldola, FC, ItalyNot Yet Recruiting
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco "Catania, Italia/Catania, ItalyNot Yet Recruiting
Azienda Ospedaliera Universitaria - CareggiFlorence, Italia/FI, ItalyNot Yet Recruiting
ARNAS G.Brotzu P.O Armando BusincoCagliari, Italy/Cagliari, ItalyNot Yet Recruiting
USL Nord Ovest Toscana - LivornoLivorno, Italy/Livorno, ItalyNot Yet Recruiting
Ospedale del Mare, ASL Napoli1 CentroNaples, italy/Napoli, ItalyNot Yet Recruiting
Istituto Oncologico VenetoPadova, Italy/Padova, ItalyRecruiting
Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Fondazione MondinoPavia, Italy/Pavia, ItalyNot Yet Recruiting
Azienda Ospedaliera Universitaria G.MartinoMessina, ME, ItalyNot Yet Recruiting
Istituto Tumori Regina Elena IRCCSRoma, RM, ItalyNot Yet Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, RM, ItalyNot Yet Recruiting

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06964815