An interventional, open-label, Phase II study, to evaluate safety and efficacy of standard and high-dose chemotherapy associated with craniospinal irradiation in patients with metastatic medulloblastoma and other embryonal tumours

Metastatic medulloblastoma and other embryonal tumours

Percentage of subjects with neurological symptoms >=G3, evaluated according to CTCAE 4.0, not present at the beginning of postoperative chemoradiotherapy and not related to the recurrence / progression of the disease - Percentage of subjects with SAE - Percentage of subjects with SAE leading to withdrawal from the study - Mortality due to adverse events

Progression free survival (PFS) defined as time frame between the date of the enrolment and the date tumour progression or death, Overall survival (OS) defined as time frame between the date of the enrolment and the death to any cause, Difference in scoring for neuropsychological (Griffiths-III, WPPSI-III, WISC-IV, WAIS-IV, Rey, Nepsy-2) and psycological (PedsQL, CBCL) scales, Rate of treatment response: CR, complete response the complete disappearance of all radiographic and/or cytological evidence of tumor; PR, partial response >= 50% reduction in the product of the perpendicular diameters of the tumor with negative cytology - SD, stable disease <= 25%reduction in tumor size; PD, progressive disease >= 25% increase in tumor size or the appearance of tumor in previously uninvolved areas, Frequency of endocrinological and visual sequelae

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