2024-518964-11-01招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
To evaluate safety of first line standard and high-dose chemotherapy associated with craniospinal irradiation in pediatric and young adult patients with high risk medulloblastoma and other embryonal tumours
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •First diagnosed, previously untreated, patients with high-risk medulloblastoma (according to WHO 2016 classification): metastatic; anaplastic or large cell; partially resected (residual volume on two floors> 1.5cm2) according to WHO classification (2016); N-MYC C-MYC amplified
- •Written informed consent obtained from the patient/parents or legal representative
- •Availability for treatment and ability to be compliant with the protocol
- •Patients with other embryonic tumors (WHO classification 2016) - embryonic tumor with C19MC-altered multilayer rosettes; embryonic tumor with multilayer rosettes not otherwise specified, medulloepithelioma, CNS neuroblastoma, CNS ganglioneuroblastoma, CNS embryonic tumor not otherwise specified, CNS embryonic tumor with rhabdoid features - of first diagnosis, previously untreated (with chemo and radiotherapy) and treated only surgically
- •First diagnosed Pinealoblastomas (WHO 2016), previously untreated (with chemo and radiotherapy) and treated only surgically
- •Males and females aged >3 years and <21 years at time of the diagnosis
- •Life expectancy > or = 12 months
- •Karnofsky/Lansky > or = 40 %
- •Adequate hematological function (leucocyte > or = 2.0 x 10^9/l - Hemoglobin > or = 10 g/dl - platelet > or = 50 x 10^9/l)
- •Adequate liver function (total bilirubin < or = 2.5 x ULN - ALT/AST < or = 5.0 x ULN)
- •Adequate renal function (serum creatinine < or = 1.5 x ULN)
排除标准
- •Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy, psychosocial problems)
- •Other contraindications reported in the SmPC
- •Administration of a first-line chemotherapy cycle at the same time as the start of the study
- •Concomitant partecipation to other clinical trial
- •Pregnancy or breastfeeding
- •Inadequate contraception by patients of both sexes
- •Hypersensibility to active principles or excipients
- •Severe bone-marrow depression
- •Concomitant administration of live attenuated vaccines
- •Inability to comply for study follow-up
结局指标
主要结局
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
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
次要结局
- 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
研究者
Clinical Trial Office
Scientific
Azienda Ospedaliera Universitaria Meyer IRCCS
研究点 (1)
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