RecruitingNot ApplicableNCT06964815

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

Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients: a Multicenter, Double-blind, Placebo-controlled, Randomized Study

Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

110 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma IDH Wild-type and STAT3-positive Glioblastoma

Summary

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)

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding silibinin (a natural compound derived from milk thistle) to the standard treatment for newly diagnosed glioblastoma (an aggressive brain tumor) can improve outcomes — specifically in tumors with an activated protein called STAT3. **You may be eligible if...** - You have a new, confirmed diagnosis of glioblastoma (according to 2021 WHO criteria) - Your tumor has tested positive for an activated form of the STAT3 protein - You are starting standard chemoradiation within 7 weeks of surgery - Your cancer has not progressed after surgery - Tumor tissue is available for testing **You may NOT be eligible if...** - Your tumor does not have the STAT3 marker - You have already started post-surgical treatment elsewhere - You have significant organ problems preventing chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSilibinin as STAT3 inhibitor

Sillbrain will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Each 3.7 g sachet of Sillbrain contains 500 mg silibinin. Every patient will assume 2 sachets/day for a total of 1 g/day of silibinin.

OTHERPlacebo

Placebo will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Every patient will assume 2 sachets/day for a total of 1 g/day of placebo.

Locations(16)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, BO, Italy

IRST Dino Amadori

Meldola, FC, Italy

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco "

Catania, Italia/Catania, Italy

Azienda Ospedaliera Universitaria - Careggi

Florence, Italia/FI, Italy

ARNAS G.Brotzu P.O Armando Businco

Cagliari, Italy/Cagliari, Italy

USL Nord Ovest Toscana - Livorno

Livorno, Italy/Livorno, Italy

Ospedale del Mare, ASL Napoli1 Centro

Naples, italy/Napoli, Italy

Istituto Oncologico Veneto

Padova, Italy/Padova, Italy

Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Fondazione Mondino

Pavia, Italy/Pavia, Italy

Azienda Ospedaliera Universitaria G.Martino

Messina, ME, Italy

Istituto Tumori Regina Elena IRCCS

Roma, RM, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Policlinico San Martino - Genova

Genova, Italy

Ospedale A. Manzoni Lecco

Lecco, Italy

Humanitas Cancer Center

Milan, Italy

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, Italy

View Full Details on ClinicalTrials.gov

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NCT06964815

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