NL-OMON54193招募中3 期
AN INTERNATIONAL PROSPECTIVE TRIAL ON HIGHRISK MEDULLOBLASTOMA IN PATIENTS OLDER THAN 3 YEARS - SIOP HR-MB
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
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) or non-SHH/non-wingless-type
- •(WNT) (Groups 3 and 4) medulloblastoma, with at least one of the following high
- •risk features:
- •o Metastatic disease: Chang Stage M1, M2 and M3
- •o Large cell/anaplastic MB (as defined by World Health Organisation (WHO)
- •criteria 2016
- •o Patients with MYC or MYCN amplified tumours (unless MYCN amplified
- •non-WNT/non-SHH Group 4 without any other high risk factors)
- •o Patients with somatic SHH-TP53 mutant tumours .
- •o Patients with significant residual tumour (> 1.5 cm2) following surgical
- •resection of the primary tumour and other biological risk factors (as above)
- •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
- •genetic 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:
- •o Total bilirubin <= 1.5 times upper limit of normal (ULN) for age, unless the
- •patient is known to have Gilbert*s syndrome
- •o ALT 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, prior to induction chemotherapy
- •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
- •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:
- •o Either Arm A (conventional radiotherapy) or Arm B (HART)
排除标准
- •Exclusion criteria for trial entry and R1:
- •Patients with proven or with high likelihood of germline TP53, APC, PTCH1,
- •SUFU, PALB2, BRCA2 gene alteration or any other DNA repair defect
- •Non-WNT/non-SHH Group 4 patients with MYCN amplification and no other
- •high-risk factor
- •Patients with CTNNB1 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
- •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
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