An international study comparing a number of treatment options for patients older than three years with medulloblastoma (a type of brain cancer) and clinical or biological features that make these patients more difficult to treat (high-risk disease)

Trial ID: ISRCTN16314648

Other - Phase 3 - Recruiting

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-treatments-for-a-brain-tumour-called-medulloblastoma-hr-mb (added 17/03/2021)

Conditions

• Medulloblastoma
• Cancer
• Medulloblastoma

Eligibility

Inclusion criteria

• Inclusion criteria for trial entry and randomisation 1: 1. 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: 1.1 Metastatic disease: Chang Stage M1, M2 and M3. 1.2 Large cell/Anaplastic MB (as defined by World Health Organisation (WHO) criteria 2016 1.3 Patients with significant residual tumour ( > 1.5 cm2) following surgical resection of the primary tumour and other biological risk factors 1.4 Patients with MYC or MYCN amplified tumours (unless MYCN amplified Group 4 without any other high risk factors) 1.5 Patients with SHH subgroup tumours harbouring somatic TP53 mutations. 2. Age at diagnosis > = 3 years. The date of diagnosis is the date on which initial surgery is undertaken. 3. 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. 4. 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 5. Adequate hepatic function defined as: 5.1 Total bilirubin < = 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert’s syndrome 5.2 ALT or AST < 2.5 X ULN for age 6. Adequate renal function defined as creatinine < 1.5 x ULN 7. Adequate haematological function defined as ANC > = 1 x 109/L; platelets > = 100 x 109/L 8. No significant hearing deficit in at least one ear (significant hearing deficit defined as Chang grade 3 or above) 9. Medically fit to receive protocol treatment 10. Documented negative pregnancy test for female patients of childbearing potential 11. Patient agrees to use effective contraception whilst on treatment (patients of childbearing potential) 12. Written informed consent from the patient and/or parent/legal guardian Inclusion criteria for Randomisation 2 (R2) 13. Patient entered into the SIOP-HRMB trial at diagnosis 14. Patient treated with either Arm A (conventional radiotherapy) or Arm B (HART) as part of R1

Exclusion criteria

• Exclusion criteria for trial entry and randomisation 1: 1. Proven or high likelihood of Germline TP53, APC, PTCH, SUFU, PALB2, BRCA2 gene alteration or any other DNA repair defect. 2. Group 4 patients with MYCN amplification and no other high-risk factor 3. β-catenin mutation positive WNT medulloblastoma irrespective of other risk factors 4. Significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and no other biological risk factors. 5. Chang Stage M4 disease 6. Brainstem or embryonal tumours in other sites 7. Previously treated for a brain tumour or any type of malignant disease 8. Medical contraindication to radiotherapy or chemotherapy 9. Hypersensitivity to any of the treatments or excipients 10. Females who are pregnant or breastfeeding 11. Cannot be regularly followed up due to psychological, social, family, geographical or other issues 12. Patients for whom non-compliance with treatment, management guidelines or monitoring is expected.

Sponsor

University of Birmingham

Source: https://www.isrctn.com/

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