Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT01351870
• Date of registration: 09/05/2011
• Prospective Registration: No
• Primary sponsor: Institut Curie
• Public title: Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma SIOP-PNET-4
• Scientific title: A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma
• Date of first enrolment: April 2004
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01351870
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: DOZ François, MD
• Affiliation: Institut Curie

Key inclusion & exclusion criteria

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.



Age minimum: 4 Years
Age maximum: 22 Years
Gender: All

Health Condition(s) or Problem(s) studied

Medulloblastoma

Intervention(s)

Radiation: Standard Fractionation Regimen

Radiation: Hyperfractionated Radiotherapy

Primary Outcome(s)

Free survival rate [Time Frame: 2 years after the start of the study]

Secondary Outcome(s)

To compare the pattern of relapse between the two treatment arms [Time Frame: Follow-up of the last patient included up to the age of 20 years]

To compare overall survival between the two treatment arms. [Time Frame: Follow-up of the last patient included up to the age of 20 years]

To explore the benefit and the risks of neurosurgery [Time Frame: Follow-up of the last patient included up to the age of 20 years]

Secondary ID(s)

IC2003-06 PNET4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors