An International Prospective Trial on High-Risk Medulloblastoma in Patients Older than 3 Years - SIOP-HRMB

IVERSITY OF BIRMINGHAM0 个研究点目标入组 850 人开始时间: 2021年8月30日最近更新: 2022年3月14日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 850

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Inclusion criteria for trial entry and R1
•Histologically proven (centrally reviewed) high-risk medulloblastoma, with any of the currently defined histological subtypes. High-risk disease is defined as patients with sonic hedgehog (SHH) subgroup or non-SHH/non-wingless-type (WNT) (Groups 3 and 4) medulloblastoma, with at least one of the following high risk features:
•oMetastatic disease: Chang Stage M1, M2 and M3.
•oLarge cell/Anaplastic MB (as defined by World Health Organisation (WHO) criteria 2016
•oPatients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and other biological risk factors
•oPatients with MYC or MYCN amplified tumours (unless MYCN amplified Group 4 without any other high risk factors)
•oPatients with SHH subgroup tumours harbouring somatic TP53 mutations.
•Age at diagnosis =3 years. The date of diagnosis is the date on which initial surgery is undertaken.
•Submission of biological material, including fresh frozen tumour samples and blood, in accordance with national and international schemes for molecular assessment of biological markers, and for associated biological studies.
•No prior treatment for medulloblastoma, other than surgery, with the exception of one cycle of induction chemotherapy with carboplatin and etoposide may be given prior to trial entry and randomisation where there is clinical urgency to start treatment
•Adequate hepatic function defined as:
•oTotal bilirubin = 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert’s syndrome
•oALT or AST < 2.5 X ULN for age
•Adequate renal function defined as creatinine < 1.5 x ULN
•Adequate haematological function defined as ANC =1 x 109/L; platelets = 100 x 109/L
•No significant hearing deficit in at least one ear (significant hearing deficit defined as Chang grade 3 or above)
•Medically fit to receive protocol treatment
•Documented negative pregnancy test for female patients of childbearing potential
•Patient agrees to use effective contraception whilst on treatment (patients of childbearing potential)
•Written informed consent from the patient and/or parent/legal guardian
•Inclusion criteria for Randomisation 2 (R2)
•Patient entered into the SIOP-HRMB trial at diagnosis
•Patient treated with:
•oEither Arm A (conventional radiotherapy) or Arm B (HART) as part of R1
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Exclusion criteria for trial entry and randomisation 1:
•Patients with proven or with high likelihood of Germline TP53, APC, PTCH, SUFU, PALB2, BRCA2 gene alteration or any other DNA repair defect.
•Group 4 patients with MYCN amplification and no other high-risk factor
•Patients with ß-catenin mutation positive WNT medulloblastoma irrespective of other risk factors
•Patients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and no other biological risk factors.
•Chang Stage M4 disease
•Brainstem or embryonal tumours in other sites
•Patients previously treated for a brain tumour or any type of malignant disease
•Medical contraindication to radiotherapy or chemotherapy
•Known hypersensitivity to any of the treatments or excipients
•Females who are pregnant or breastfeeding
•Patients who cannot be regularly followed up due to psychological, social, family, geographical or other issues
•Patients for whom non-compliance with treatment, management guidelines or monitoring is expected.

研究者

发起方

IVERSITY OF BIRMINGHAM

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