Clinical trial · Interventional
Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma (PNET4)
A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma
NCT01351870CI-TRIAL-00095136SIOP-PNET-4completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperfractionated Radiotherapy | Radiation | — | UNRESOLVED |
| Standard Fractionation Regimen | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Fractionation Regimen
- description
- 1.8 Gy daily, 5 fractions per week Cranio-spinal axis: 23.4 Gy in 13 fractions of 1.8 Gy Posterior fossa: 30.6 Gy in 17 fractions of 1.8 Gy
- interventionNames
- Radiation: Standard Fractionation Regimen
- type
- EXPERIMENTAL
- label
- Hyperfractionated radiotherapy
- description
- 1 Gy b.d. (minimum interval between fractions 8 hours). 10 fractions per week Craniospinal axis: 36 Gy in 36 fractions of 1 Gy Posterior fossa: 24 Gy in 24 fractions of 1 Gy Tumour Bed: 8 Gy in 8 fractions of 1 Gy
- interventionNames
- Radiation: Hyperfractionated Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years. * Histologically proven medulloblastoma, including the following variants(WHO classification - 2000): classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI - supratentorial, arachnoid of the posterior fossa or spine. * No clinical evidence of extra-CNS metastasis * No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy. * Radiotherapy to start no more than 40 days after surgery. * Ability to receive twice daily radiotherapy. * Vital functions within normal range for their age group. * CTC grades \< 2 for liver, renal, haematological and audiological function. * No medical contraindication to radiotherapy or chemotherapy. * Written informed consent (and patient assent where appropriate) according to the laws of each participating country. Written informed consent should also be sought for biological studies. * National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies). Exclusion Criteria: * One of the inclusion criteria is lacking. * Brainstem or supratentorial primitive neuroectodermal tumour. * Atypical teratoid rhabdoid tumour. * Medulloepithelioma. * Ependymoblastoma. * Large cell médulloblastoma. * Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF). * Patient previously treated for a brain tumour or any type of malignant disease. * Patients who are pregnant. * Females who are sexually active and not taking reliable contraception. * Known predisposition to medulloblastoma e.g. Gorlin's syndrome.
References
Publications (1)
- DERIVEDGoschzik T, Schwalbe EC, Hicks D, Smith A, Zur Muehlen A, Figarella-Branger D, Doz F, Rutkowski S, Lannering B, Pietsch T, Clifford SC. Prognostic effect of whole chromosomal aberration signatures in standard-risk, non-WNT/non-SHH medulloblastoma: a retrospective, molecular analysis of the HIT-SIOP PNET 4 trial. Lancet Oncol. 2018 Dec;19(12):1602-1616. doi: 10.1016/S1470-2045(18)30532-1. Epub 2018 Nov 1. PMID 30392813