Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).
- Registration Number
- NCT06297512
- Lead Sponsor
- Iacopo Sardi
- Brief Summary
Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy).
- Males and females between the ages of 3 and 30 years old
- Life expectancy ≥ 12 months
- karnofsky/Lansky ≥ 80 %
- Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/l, Hemoglobin ≥ 10 g/dl, Platelet count ≥ 50 x 109/l
- Adequate liver function: Total bilirubin ≤ 2.5 x ULN, ALT/AST ≤ 5.0 x ULN
- Adequate renal function:Serum creatinine ≤ 1.5 x ULN
- Written informed consent from the patient, parents or legal guardians
- Patient's willingness during treatment and ability to comply with the protocol
- Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease)
- Performance of a course of 1st-line chemotherapy at the same time as study initiation
- Concurrent participation in other research projects
- Pregnancy or lactation status
- Use of inappropriate contraceptive methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pGBM patients therapy Radiotherapy, Temozolomide, Doxorubicin * Whole therapy radiation therapy * Temozolomide concomitant * After 1 month adjuvant Temozolomide, * After 3 months Doxorubicine * adjuvant Temozolomide
- Primary Outcome Measures
Name Time Method Percentage of Withdrawal from the study rate through study completion, an average of 1 year Percentage of subjects with SAE leading to withdrawal from the study
Percentage of SAEs through study completion, an average of 1 year Percentage of SAEs
Evaluation prolonged Dox through study completion, an average of 1 year Time to early withdrawal from experimental treatment with Dox
Early discontinuation of dox treatment rate through study completion, an average of 1 year Proportion of early discontinuation of experimental treatment with Dox
Mortality rate through study completion, an average of 1 year Mortality from adverse events
- Secondary Outcome Measures
Name Time Method Event-free survival (EFS), disease progression (PFS), and overall survival (OS) through study completion, an average of 1 year Event-free survival (EFS) calculated as the time between the date of enrolment and the date of occurrence of one of the events:
* disease progression established according to the modified RANO criteria for paediatric age
* clear progression of non-measurable lesions (T1);
* - any new lesion;
* clinical deterioration due to the tumour and not attributable to other causes (e.g, seizures, adverse drug effects, complications of therapy, cerebrovascular events infections and so on);
* failure to return for evaluation following death (from any cause) or deterioration of condition;
* and other described in the protocol
Trial Locations
- Locations (1)
Meyer Children's Hospital IRCCS
🇮🇹Florence, Italy