NCT06964815
Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients
Recruiting · Not Applicable · Istituto Oncologico Veneto IRCCS · registry updated 2025-12-02
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)
Inclusion
- 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 without disease progression after surgery
- Availability of paraffin-embedded tumor tissue
Exclusion
- 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
- In the investigator's judgment, any evidence of severe or uncontrolled systemic disease including: uncontrolled hypertension; hemorrhagic diathesis; active infection with HBV, HCV, HIV. Screening for such chronic conditions is not required by the protocol; bone marrow reserve or organ dysfunction as demonstrated by laboratory tests.
- Patients who are unable to comply with study procedures and requirements.