Phase
Condition
Brain Tumor
Gliomas
Brain Cancer
Treatment
Hyperfractionated Radiotherapy
Standard Fractionation Regimen
Clinical Study ID
Ages 4-22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age at diagnosis at least 4 years or 5 years (according to the policy of theNational Brain Tumour Group) and less than 22 years.
Histologically proven medulloblastoma, including the following variants(WHOclassification - 2000): classic medulloblastoma, nodular / desmoplasticmedulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis onMRI - 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 isrecommended 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 thelaws of each participating country. Written informed consent should also be soughtfor biological studies.
National and local ethical committee approval according to the laws of eachparticipating country (to include approval for biological studies).
Exclusion
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 postoperativelumbar 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.
Study Design
Study Description
Connect with a study center
Institut Curie
Paris, 75005
FranceSite Not Available
Institut Curie
Paris 2988507, 75005
FranceSite Not Available

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