Last updated: January 29, 2024
Sponsor: Institut Curie
Overall Status: Completed
Phase
3
Condition
Brain Tumor
Gliomas
Brain Cancer
Treatment
Hyperfractionated Radiotherapy
Standard Fractionation Regimen
Clinical Study ID
NCT01351870
IC2003-06 PNET4
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 the NationalBrain 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 the lawsof each participating country. Written informed consent should also be sought forbiological 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
Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Hyperfractionated Radiotherapy
Phase: 3
Study Start date:
April 01, 2004
Estimated Completion Date:
March 31, 2020
Study Description
Connect with a study center
Institut Curie
Paris, 75005
FranceSite Not Available
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