Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3… (NCT06964815) | Clinical Trial Compass
RecruitingNot Applicable
Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients
Italy110 participantsStarted 2025-11-12
Plain-language 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)
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* 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
* Age ≥18 years
* ECOG PS 0-2; Karnofsky 100-70
* Signing of informed consent prior to any study procedure
* Patients (both males and females) should employ adequate contraceptive measures, which should be maintained during the whole duration of the trial (from screening to 6 months after the last dose of Temozolomide).
* Have adequate bone marrow, liver and kidney function, as measured by the following laboratory assessments conducted within 10 days before the start of study treatment:
* Hemoglobin \> 9.0 g/dl
* Absolute neutrophil count (ANC) ≥1500/mm3 without granulocyte colony-stimulating factor (G-CSF) and other hematopoietic growth factors
* Platelet count ≥100,000/μl
* WBC ≥3.0 x 10 9 /L
* Total bilirubin \<1.5 times the upper limit of normal
* ALT and AST \<3 x the upper limit of normal
* Serum creatinine \<1.5 times the upper limit of normal
* Glomerular filtration rate ≥ 30 mL/min/1.73 m2 according to the abbreviated formula Modified Diet in Renal Disease
* Alkaline ph…
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Through study completion, an average of 2 years