PNET5 MB

 Classic medulloblastoma / Posted 1 year ago

A study looking at improving treatment for children and young people with medulloblastoma (PNET5 MB)

The PNET 5 study has been designed for children and young people aged from 3 yrs to 22 yrs with standard risk medulloblastoma who have undergone surgery to remove the primary tumour. The presence of biological markers of the WNT medulloblastoma disease subgroup (mutation of the beta-catenin gene, or presence of the beta-catenin protein and loss of chromosome 6) and aged < 16 defines the patient as Low Risk biological profile. The presence of the WNT markers and aged 16 and over, or the absence of the WNT markers defines the patient as Standard Risk biological profile.
Low risk group patients will receive reduced doses of radiotherapy (compared to previous study PNET 4) to the brain and spine every day for 10 days, together with boost doses to the primary tumour for a further 20 days.
Maintenance chemotherapy will consist of 6 cycles of Regimen A alternating with 6 cycles of Regimen B for a total duration of 27 weeks.
Standard risk group patients will be randomised into two arms. One arm will receive doses of radiotherapy to the brain and spine every day for 13 days, together with boost doses to the primary tumour for a further 17 days, and the other arm will receive the radiotherapy together with the drug Carboplatin.
Maintenance chemotherapy will consist of 8 cycles of Regimen A alternating with 8 cycles of Regimen B for a total duration of 36 weeks.
The primary objectives of the study are :-
* to confirm the 3 year Event Free Survival rate in low risk biological profile patients remains in excess of 80% when patients receive reduced intensity radiotherapy and chemotherapy,
* to test whether the Event Free Survival rate in standard risk biological profile patients is different for patients treated with or without carboplatin concomitantly with radiotherapy, followed by a modified maintenance chemotherapy.

 

  • Inclusion Criteria :
    • You have had surgery to remove your medulloblastoma and there are no signs that the cancer has spread anywhere else in your brain or spine
    • You have not had any other treatment for your medulloblastoma other than surgery
    • Your surgeon was able to send a suitable sample of your medulloblastoma for tests in the laboratory
    • You are able to have radiotherapy and chemotherapy
    • You are able to start radiotherapy within 28 days of your operation
    • You have satisfactory liver and kidney function
    • You have no significant hearing loss
    • If you are female and sexually active, you need to use reliable contraception during the time you are on the trial
    • You are aged between 3 and up to age 22. The doctors will use the age you are when you have your surgery
  • Exclusion Criteria :
    • Have a high risk medulloblastoma or the doctors are not able to tell from your cancer what risk group you are
    • Have 1 of the following types of tumours: brainstem or supratentorial primitive neuro ectodermal tumour, atypical teratoid rhabdoid tumour, medulloepithelioma, ependymoblastoma, large cell medulloblastoma anaplastic medulloblastoma, medulloblastoma with extensive nodularity (MBEN).
    • Have had treatment for any other type of brain tumour or cancer in the past
    • Have a condition which could affect you having chemotherapy or radiotherapy such as Fanconi anaemia , Nijmegen breakage syndrome, or Gorlin’s syndrome
    • Have Turcot syndrome or Li-Fraumeni syndrome
    • Are pregnant
    • Have any other condition that the trial team think could affect you taking part
  • Study start date : 10/01/2017
  • Study end date : 01/01/2023
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Antony Michalski

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