Overview

This trial is active, not recruiting.

Condition medulloblastoma
Treatments standard fractionation regimen, hyperfractionated radiotherapy
Phase phase 3
Sponsor Institut Curie
Start date April 2004
End date December 2008
Trial size 52 participants
Trial identifier NCT01351870, IC2003-06

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
1.8 Gy daily, 5 fractions per week Cranio-spinal axis: 23.4 Gy in 13 fractions of 1.8 Gy Posterior fossa: 30.6 Gy in 17 fractions of 1.8 Gy
standard fractionation regimen
1.8 Gy daily, 5 fractions per week Cranio-spinal axis: 23.4 Gy in 13 fractions of 1.8 Gy Posterior fossa: 30.6 Gy in 17 fractions of 1.8 Gy
(Experimental)
1 Gy b.d. (minimum interval between fractions 8 hours). 10 fractions per week Craniospinal axis: 36 Gy in 36 fractions of 1 Gy Posterior fossa: 24 Gy in 24 fractions of 1 Gy Tumour Bed: 8 Gy in 8 fractions of 1 Gy
hyperfractionated radiotherapy
1 Gy b.d. (minimum interval between fractions 8 hours). 10 fractions per week Craniospinal axis: 36 Gy in 36 fractions of 1 Gy Posterior fossa: 24 Gy in 24 fractions of 1 Gy Tumour Bed: 8 Gy in 8 fractions of 1 Gy

Primary Outcomes

Measure
Free survival rate
time frame: 2 years after the start of the study

Secondary Outcomes

Measure
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 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 explore the benefit and the risks of neurosurgery
time frame: Follow-up of the last patient included up to the age of 20 years

Eligibility Criteria

Male or female participants from 4 years up to 22 years old.

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.

Additional Information

Official title A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma
Principal investigator DOZ François, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institut Curie.