Clinical Trial: Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Institut Curie

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

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Will hyperfractionated radiotherapy lead to a different progression free (PFS) and overall survival (OS) compared to the standard arm radiotherapy?
  • 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 ]
    Will hyperfractionated RT lead to a different pattern of local tumour control/pattern of relapse with particular respect to local relapse (tumour bed, posterior fossa outside the tumour bed) compared to the standard arm RT? The time to local progression should be the measure for the local tumour control.
  • 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 ]

    To determine the toxicity of surgery.To investigate whether there are identifiable factors that correlate with toxicity.

    To define the impact of any complications of surgery on commencement of adjuvant therapy and on EFS.



Original Secondary Outcome: Same as current

Information By: Institut Curie

Dates:
Date Received: May 9, 2011
Date Started: April 2004
Date Completion: December 2019
Last Updated: July 11, 2016
Last Verified: July 2016