EUCTR2011-004868-30-DK进行中（未招募）1 期
AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR and PNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION AND REGISTRY FOR MB OCCURRING IN THE CONTEXT OF GENETIC PREDISPOSITIO
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 410 人开始时间: 2019年6月12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
- 410
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
- •General inclusion criteria all studies
- •Submission of high quality biological material incl. fresh frozen tumour samples and blood
- •CTC grades < 2 for liver, renal, haematological function
- •Central pathology review, central molecular diagnosis of genetically defined subgroup, and central MRI mandatory
- •Cytospin of lumbar CSF
- •Written informed consent
- •National and local ethical committee approval
- •Common inclusion criteria LR, SR, WNT-HR
- •No prior therapy for medulloblastoma (MB) other than surgery
- •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
- •Inclusion of patients is not possible later than 40 days after first tumour surgery, or after start of radiotherapy
- •No significant sensineural hearing deficit
- •No identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. No unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours
- •No other medical contraindication to radiotherapy or chemotherapy
- •Specific inclusion criteria LR
- •Age at diagnosis >3-5 and <16 years
- •MB, WNT-activated; histologic subtypes: MB, classic and desmoplastic/nodular
- •Clinically standard -risk MB, defined as total or near total surgical resection with less than or equal to 1.5 cm2 of residual tumour on early post-operative MRI, without and with contrast, on central review; no CNS metastasis on MRI on central review; no tumour cells on the cytospin of lumbar CSF, no clinical evidence of extra-CNS metastasis; 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
- •No amplification of MYC or MYCN
- •Low-risk biological profile, defined as presence of ß-catenin mutation resulting in WNT activation
- •Specific inclusion criteria SR-study
- •Age at diagnosis >3-5 and <22 years
- •MB, SHH-activated and TP53-wildtype; MB, non-WNT/non-SHH; MB, group 3; MB, group 4; Histologic subtype: MB, classic and desmoplastic/nodular
- •Clinically standard-risk, defined as total or near total surgical resection with less than or equal to 1.5 cm2 of residual tumour on early post-operative MRI, without and with contrast, on central review; no CNS metastasis on MRI on central review; no tumour cells on the cytospin of lumbar CSF; no clinical evidence of extra-CNS metastasis; 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
- •No amplification of MYC or MYCN; MYCN amplification allowed for patients with group 4 MB
- •WNT-subgroup negativity is prerequisite: WNT-negative tumours are defined by ß-catenin nuclear immuno-negativity by IHC, and the absence of ß-catenin mutation
- •For patients with SHH activated tumours: exclusion of germline alteration of TP53, PTCH and SUFU is required. Exclusion of somatic mutation is sufficient for enrolment of the patient. In case of somatic alteration, urgent diagnostic evaluation for germline alteration after appropriate consent is necessary. Patients with germline TP53, PTCH, SUFU, BRCA2, or PALB2 alteration are not eligible for the study
- •Specific inclusion criteria W
排除标准
- •Exclusion criteria LR
- •a) One of the inclusion criteria is lacking;
- •b) Brainstem or supratentorial embryonal tumour;
- •c) Atypical teratoid rhabdoid tumour;
- •d) Medulloepithelioma, embryonal tumour with multi-layered rosettes.
- •e) Large cell/anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), confirmed on central pathological review.
- •f) Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or WNT subgroup status not determinable.
- •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) identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. Unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours
- •j) identified somatic TP53 mutation
- •k) Patients who are pregnant;
- •l) Female patients who are sexually active and not taking reliable contraception;
- •m) Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons;
- •n) Patients in whom non-compliance with toxicity management guidelines can be expected.
- •Exclusion criteria SR
- •a) One of the inclusion criteria is lacking;
- •b) Brainstem or supratentorial embryonal tumour;
- •c) Atypical teratoid rhabdoid tumour;
- •d) Medulloepithelioma, embryonal tumour with multi-layered rosettes;
- •e) Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), confirmed on central pathological review;
- •f) Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or WNT subgroup status not determinable, MYCN amplification allowed for patients with group 4 medulloblastoma;
- •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) identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. Unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours
- •j) identified somatic TP53 mutation
- •k) Patients who are pregnant;
- •l) Female patients who are sexually active and not taking reliable contraception;
- •m) Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons;
- •n) Patients in whom non-compliance with toxicity management guidelines can be expected.
- •Exclusion criteria WNT-HR
- •a) One of the inclusion criteria is lacking.
- •b) Brainstem or supratentorial embryonal tumour.
- •c) Atypical teratoid/rhabdoid tumour.
- •d) Medulloepithelioma, embryonal tumour with multi-layered rosettes.
- •e) Undeterminable biological profile, defined as WNT subgroup status not determinable.
- •f) Patient previously treated for a brain tumour or any type of malignant disease.
- •g) Identified germline APC, BRCA2, PALB2, PTCH, SUFU, or TP53 gene alteration.
- •Unrefuted clinical suspect for biallelic mismatch repair syndrome, Fanconi anaemia, Gorlin syndrome, Li-Fraumeni syndrome, patient or familial APC-a
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