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 PREDISPOSITION - SIOP PNET 5 MB

niversity Medical Centre Hamburg-Eppendorf0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 30

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

入排标准

年龄范围: 2 至 99（—）

入选标准

•GENERAL INCLUSION CRITERIA ALL STUDIES
•1. Submission of high quality biological material incl. fresh frozen tumour
•samples and blood
•2. CTC grades < 2 for liver, renal, haematological function
•3. Central pathology review, central molecular diagnosis of genetically defined
•subgroup, and central MRI mandatory
•4. Cytospin of lumbar CSF
•5. Written informed consent
•6. National and local ethical committee approval
•COMMON INCLUSION CRITERIA FOR LR, SR AND WNT-HR
•1. No prior therapy for medulloblastoma (MB) other than surgery
•2. 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
•3. No significant sensineural hearing deficit
•4. 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
•5. No other medical contraindication to radiotherapy or chemotherapySPECIFIC
•INCLUSION CRITERIA LR-STUDY
•1. Age at diagnosis > 3-5 and < 16 years
•2. MB, WNT-activated; histologic subtypes: MB, classic and desmoplastic/nodular
•3. 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
•4. No amplification of MYC or MYCN
•5. Low-risk biological profile, defined as presence of β-catenin mutation
•resulting in WNT activation
•SPECIFIC INCLUSION CRITERIA SR-STUDY
•1. Age at diagnosis >3-5 and <22 years
•2. MB, SHH-activated and TP53-wildtype; MB, non-WNT/non-SHH; MB, group 3; MB,
•group 4; Histologic subtype: MB, classic and desmoplastic/nodular
•3. 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
•4. No amplification of MYC or MYCN; MYCN amplification allowed for patients
•with group 4 MB
•5. WNT-subgroup negativity is prerequisite: WNT-negative tumours are defined by
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排除标准

•EXCLUSION CRITERIA PNET-5 MB - LR and PNET-5 MB - SR:
•Exclusion criteria LR
•1. One of the inclusion criteria is lacking;
•2. Brainstem or supratentorial embryonal tumour;
•3. Atypical teratoid rhabdoid tumour;
•4. Medulloepithelioma, embryonal tumour with multi-layered rosettes.
•5. Large cell/anaplastic medulloblastoma, or medulloblastoma with extensive
•nodularity (MBEN), confirmed on central pathological review.
•6. Unfavourable or undeterminable biological profile, defined as amplification
•of MYC or MYCN, or WNT subgroup status not determinable.
•7. Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of
•postoperative lumbar CSF);
•8. Patient previously treated for a brain tumour or any type of malignant
•9. 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;
•10. Patients who are pregnant;
•11. Female patients who are sexually active and not taking reliable
•contraception;
•12. Patients who cannot be regularly followed up due to psychological, social,
•familial or geographic reasons;
•13. Patients in whom non-compliance with toxicity management guidelines can be
•Exclusion criteria SR
•1. One of the inclusion criteria is lacking;
•2. Brainstem or supratentorial embryonal tumour;
•3. Atypical teratoid rhabdoid tumour;
•4. Medulloepithelioma, embryonal tumour with multi-layered rosettes;
•5. Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma
•with extensive nodularity (MBEN), confirmed on central pathological review;
•6. 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;
•7. Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of
•postoperative lumbar CSF);
•8. Patient previously treated for a brain tumour or any type of malignant
•9. 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
•10. identified somatic TP53 mutation in SHH activated tumours
•11. Patients who are pregnant;
•12. Female patients who are sexually active and not taking reliable
•contraception;
•13. Patients who cannot be regularly followed up due to psychological, social,
•familial or geographic reasons;
•14. Patients in whom non-compliance with toxicity management guidelines can be
•Exclusion criteria WNT-HR
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研究者

发起方

niversity Medical Centre Hamburg-Eppendorf

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