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A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

Phase 3
4 Years
22 Years
Open (Enrolling)

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Trial Information

A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Free survival rate

Outcome Description:

To compare in a randomised trial the event free survival rate for children and adolescents with standard risk medulloblastoma treated with either hyperfractionated radiotherapy or reduced dose radiotherapy with conventional fractionation.

Outcome Time Frame:

2 years after the start of the study

Safety Issue:


Principal Investigator

DOZ François, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2004

Completion Date:

December 2016

Related Keywords:

  • Medulloblastoma
  • Medulloblastoma