Actively Recruiting
Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients
Led by Istituto Oncologico Veneto IRCCS · Updated on 2025-12-02
110
Participants Needed
16
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New histologically confirmed diagnosis of glioblastoma (WHO 2021)
- Local availability of MGMT methylation status
- Positive activated STAT3 expression on tumor tissue sample
- Chemoradiotherapy start within 7 weeks from surgery
- No disease progression after surgery
- Availability of paraffin-embedded tumor tissue
- Age 18 years or older
- ECOG performance status 0-2; Karnofsky score 70-100
- Signed informed consent before study procedures
- Use of adequate contraception during study and for 6 months after last temozolomide dose
- Adequate bone marrow, liver, and kidney function within 10 days before treatment
- Stable and decreasing corticosteroid dose in last 10 days before brain MRI
You will not qualify if you...
- Glioblastoma patients who only had diagnostic biopsy
- Prior chemotherapy, immunotherapy, or antineoplastic therapy for glioblastoma
- Negative STAT3 expression on tumor tissue
- Diagnosis of another tumor or secondary brain cancer
- Severe or uncontrolled systemic diseases (e.g. uncontrolled hypertension, hemorrhagic diathesis, active HBV/HCV/HIV infection)
- Unable to comply with study procedures
- Contraindication to brain MRI
- Pregnant or breastfeeding
- Unable to swallow capsules or sachets dissolved in water
- Unable to sign informed consent
- Glioblastoma leptomeningeal dissemination
- Congestive heart failure NYHA class 2 or higher; unstable or recent angina; recent myocardial infarction; cardiac arrhythmias requiring therapy (except beta-blockers or digoxin); uncontrolled hypertension despite medical management
- Recent arterial thrombotic or embolic events or pulmonary embolism within 6 months
- Ongoing infection grade 2 or higher
- History of HIV or active hepatitis B or C requiring antiviral treatment
- History of organ transplantation
- Any bleeding disorder
- Unhealed injuries, ulcers, or bone fractures
- Renal failure requiring dialysis
- Interstitial lung disease with current symptoms
- Persistent proteinuria ≥3.5 g/24 hours
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Trial Site Locations
Total: 16 locations
1
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, BO, Italy, 40139
Not Yet Recruiting
2
IRST Dino Amadori
Meldola, FC, Italy, 47014
Not Yet Recruiting
3
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco "
Catania, Italia/Catania, Italy, 95123
Not Yet Recruiting
4
Azienda Ospedaliera Universitaria - Careggi
Florence, Italia/FI, Italy, 50134
Not Yet Recruiting
5
ARNAS G.Brotzu P.O Armando Businco
Cagliari, Italy/Cagliari, Italy, 09047
Not Yet Recruiting
6
USL Nord Ovest Toscana - Livorno
Livorno, Italy/Livorno, Italy, 57124
Not Yet Recruiting
7
Ospedale del Mare, ASL Napoli1 Centro
Naples, italy/Napoli, Italy, 80147
Not Yet Recruiting
8
Istituto Oncologico Veneto
Padova, Italy/Padova, Italy, 35128
Actively Recruiting
9
Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Fondazione Mondino
Pavia, Italy/Pavia, Italy, 27100
Not Yet Recruiting
10
Azienda Ospedaliera Universitaria G.Martino
Messina, ME, Italy, 98124
Not Yet Recruiting
11
Istituto Tumori Regina Elena IRCCS
Roma, RM, Italy, 00128
Not Yet Recruiting
12
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
Not Yet Recruiting
13
Policlinico San Martino - Genova
Genova, Italy
Not Yet Recruiting
14
Ospedale A. Manzoni Lecco
Lecco, Italy, 23900
Not Yet Recruiting
15
Humanitas Cancer Center
Milan, Italy, 20089
Not Yet Recruiting
16
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italy, 20157
Not Yet Recruiting
Research Team
G
Giuseppe Lombardi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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