PNET 5

 Medulloblastoma / Posted 1 year ago

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

  • Study start date : 10/01/2017
  • Study end date : 23/12/2022
  • Wales-Based Study Contact : please speak to your clinician
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