Classic medulloblastoma / Posted 2 years 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.