Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT02758366
Eligibility Criteria:
Inclusion Criteria:
* Males and females patients, aged \>3 years and \< 30 years;
* Newly diagnosed of GBM, DIPG, diffuse brainstem glioma, diffuse spinal glioma, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma;
* Patients undergone either surgery or biopsy only;
* No prior chemotherapy and/or radiotherapy;
* Life expectancy ≥ 4 weeks;
* Karnofsky/Lansky ≥ 40 %;
* Written informed consent obtained from the patient/parents or legal representative;
* Adequate hematological function (leucocyte ≥ 2.0 x 10\^9/l -Hemoglobin ≥ 10 g/dl - platelet ≥ 50 x 10\^9 /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);
* Adherence to trial treatment and compliance with the protocol
Exclusion Criteria:
* Any disease or condition that contraindicates the use of the study drug (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
* Prior anti-cancer therapy
* Pregnancy or breastfeeding
* Non adequate contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
30 Years
Study:
NCT02758366
Study Brief:
Protocol Section:
NCT02758366