Temozolomide for Glioblastoma

Inclusion criteria

• {"criterion_text":"- Patients with histological-molecular diagnosis according to WHO 2016 classification: Glioblastoma IDH-wildtype (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH glioblastoma mutant (9445/3), NOS glioblastoma (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic, or previously untreated gliomatosis cerebri contextes (with chemo and radiotherapy) or treated only surgically (total, almost partial, partial, biopsy)."}
• {"criterion_text":"- Males and females between the ages of 3 and 30"}
• {"criterion_text":"- Life expectancy > or = 12 months"}
• {"criterion_text":"- Karnofsky/Lansky > o = 80%"}
• {"criterion_text":"- Adequate haematological function: Absolute white blood cell count >= 2.0 x 10^9 /l; Hemoglobin >= 10 g/dl; Platelet count >= 50 x 109/l"}
• {"criterion_text":"- Adequate liver function: Total bilirubin <= 2.5 x ULN; ALT / AST <= 5.0 x ULN"}
• {"criterion_text":"- Adequate renal function: Serum creatinine <= 1.5 x ULN"}
• {"criterion_text":"- Written informed consent from the patient, parents or legal guardians"}
• {"criterion_text":"- Patient availability during treatment and ability to comply with the protocol"}

Exclusion criteria

• {"criterion_text":"- Evidence of any other serious illness or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe congenital syndromes, heart disease)"}
• {"criterion_text":"- Perform a 1st line chemotherapy cycle at the same time as the start of the study"}
• {"criterion_text":"- Simultaneous participation in other research projects"}
• {"criterion_text":"- State of pregnancy or breastfeeding"}
• {"criterion_text":"- Use of inadequate contraceptive methods"}

Primary endpoints

• {"endpoint_text":"- Time to early discontinuation of the experimental treatment with Doxorubicin","definition_or_measurement_approach":"Measured as time from start of experimental treatment to early discontinuation of doxorubicin."}
• {"endpoint_text":"- Percentage of subjects with Serious Adverse Events (SAE) that lead to withdrawal from the study","definition_or_measurement_approach":"Calculated as proportion of enrolled subjects experiencing SAE that result in withdrawal from the study."}
• {"endpoint_text":"- Percentage of SAE","definition_or_measurement_approach":"Reported as the percentage of subjects experiencing Serious Adverse Events."}
• {"endpoint_text":"- Mortality due to adverse events","definition_or_measurement_approach":"Count and proportion of deaths attributed to adverse events."}
• {"endpoint_text":"- Proportion of early discontinuation of the experimental treatment with Doxorubicin","definition_or_measurement_approach":"Proportion of subjects who discontinue the experimental doxorubicin treatment prematurely."}

Secondary endpoints

• {"endpoint_text":"- Event-free survival (EFS) that is the time between the date of enrollment and the date of occurrence of one of the following events: disease progression, any new lesions, clinical deterioration due to the tumor; failure to return for evaluation following death or deterioration of conditions.","definition_or_measurement_approach":"EFS measured as time from enrollment to first occurrence of listed events."}
• {"endpoint_text":"- Overall survival (OS) defined as the time between the date of enrollment and the date of death from any cause","definition_or_measurement_approach":"OS measured as time from enrollment to death from any cause."}
• {"endpoint_text":"- Progression-free survival (PFS) defined as the time between the date of enrollment and the date of progression according to modified RANO criteria","definition_or_measurement_approach":"PFS measured as time from enrollment to disease progression per modified RANO criteria."}
• {"endpoint_text":"- Proportion of treatment responder (CR, complete responder; PR, partial responder; SD, stable disease; PD, disease progression) according to modified RANO criteria","definition_or_measurement_approach":"Response rates determined per modified RANO criteria and reported as proportions for CR, PR, SD, PD."}

Italy

Earliest CTIS Part Ii Submission Date

22-11-2024

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

270

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Azienda Ospedaliera Universitaria Meyer IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy