Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

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

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.

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

Patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated (twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will receive identical chemotherapy consisting of eight weekly doses of Vincristine given with radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.

Connect with a study center

  • Institut Curie

    Paris, 75005
    France

    Site Not Available

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