EUCTR2011-004868-30-GB进行中（未招募）1 期
AN INTERNATIONAL PROSPECTIVE TRIAL ONMEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR andPNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE(PNET 5 MB -SR), OR TP53 MUTATION, AND REGISTRY FORMB OCURRING IN THE CONTEXT OF GENETICPREDISPOSITION - PNET 5
niversity Medical Centre Hamburg - Eppendorf0 个研究点目标入组 360 人开始时间: 2015年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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
- •Note: with the exception of criterion f), the Inclusion Criteria are the same for PNET 5 MB - LR and PNET 5 MB - SR.
- •To be eligible for inclusion in either study, patients must meet all of the following criteria:
- •a)Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 16.0 years (LR-arm) or 22.0 years (SR-arm).
- •The date of diagnosis is the date on which first surgery/biopsy is undertaken.
- •b)Histologically proven medulloblastoma, including the following subtypes, as defined in the WHO classification (2007):
- •Classic medulloblastoma
- •Desmoplastic/nodular medulloblastoma
- •Pre-treatment central pathology review is considered mandatory.
- •c)Standard risk medulloblastoma, defined as:
- •total or near total surgical resection with less than or equal to 1.5 cm2 (measured on axial plane) of residual tumour on early postoperative MRI, without and with contrast, on central review;
- •no CNS metastasis on MRI (cranial and spinal) on central review;
- •no tumour cells on the cytospin samples of lumbar CSF (see chapter 8.1.2. Post-operative Period, page 58), according to national regulations a CSF review might me required.
- •no clinical evidence of extra-CNS metastasis.
- •In patients with significant residual tumour (> 1.5 cm2) after first surgery, secondary surgery should be considered. Patients with a reduction of postoperative residual tumour through second surgery to less than or equal to 1.5 cm2 are eligible, if timeline for start of radiotherapy can be kept.
- •d)Submission of high quality biological material including fresh frozen tumour samples for the molecular assessment of biological markers (such as the assessment of MYC gene copy number status) in national biological reference centers. Submission of blood is mandatory for all patients, who agree on germline DNA studies. Submission of CSF is recommended.
- •e)No amplification of MYC or MYCN (determined by FISH).
- •f)For PNET 5 MB - LR, low-risk biological profile, defined as WNT subgroup positivity, in patients aged <16.0 years at diagnosis. The WNT subgroup is defined by the presence of (i) ß-catenin mutation (mandatory testing), or (ii) ß-catenin nuclear immuno-positivity by IHC (mandatory testing) and ß-catenin mutation, or (iii) ß-catenin nuclear immuno-positivity by IHC and monosomy 6 (optional testing).
- •For PNET 5 MB - SR, average-risk biological profile, defined as WNT subgroup negativity. WNT-negative tumours are defined by (i) ß-catenin nuclear immuno-negativity by IHC (mandatory testing), and the absence of ß-catenin mutation (mandatory testing) and monosomy 6 (optional testing), or (ii) ß-catenin nuclear immuno-positivity by IHC (mandatory testing) in the absence of ß-catenin mutation and monosomy 6, or (iii) monosomy 6 in the absence of ß-catenin nuclear immuno-positivity by IHC or ß-catenin mutation.
- •WNT subgroup positive tumours arising in patients age =16.0 years at diagnosis. The WNT subgroup is defined by the presence of (i) ß-catenin mutation (mandatory testing), or (ii) ß-catenin nuclear immuno-positivity by IHC (mandatory testing) and ß-catenin mutation, or (iii) ß-catenin nuclear immuno-positivity by IHC and monosomy 6 (optional testing).
- •g)No prior therapy for medulloblastoma other than surgery.
- •h)Radiotherapy aiming to start no more than 28 days after surgery. Foreseeable inability to start radiotherapy within 40 days after surgery renders patients ineligible for the study.
- •i)Screening for t
排除标准
- •Exclusion Criteria
- •Note: the Exclusion Criteria are the same for PNET 5 MB - LR and PNET 5 MB - SR.
- •To be eligible for inclusion in either study, patients must meet none of the following criteria:
- •a) One of the inclusion criteria is lacking.
- •b) Brainstem or supratentorial primitive neuro-ectodermal tumour.
- •c) Atypical teratoid rhabdoid tumour.
- •d) Medulloepithelioma Ependymoblastoma.
- •e) Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), centrally confirmed.
- •f) Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or not determinable MYC or MYCN or WNT subgroup status.
- •g) Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF).
- •h) Patient previously treated for a brain tumour or any type of malignant disease.
- •i) DNA breakage syndromes (e.g. Fanconi anemia, Nijmegen breakage syndrome) or other, or identified Gorlin, Turcot, or Li Fraumeni syndrome.
- •j) Patients who are pregnant.
- •k) Female patients who are sexually active and not taking reliable contraception.
- •l) Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons.
- •m) Patients in whom non-compliance with toxicity management guidelines can be expected.
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