Updated UK specific appendix to protocol v3.0; Updated induction PIS for parents/guardians and patients aged 16+; Addition of a Flyer introducing the new patient friendly videos.
UK Specific Protocol Appendix
Addition of dose modifications for patients of low (≤10Kg) body weight for the two drugs Temozolomide and Irinotecan that are involved in the TEMIRI regimen.
Clarification of the criteria to be met prior to each cycle of 13-cis-RA and dinutuximab beta.
Patient Information Sheets
The patient information sheets for the induction randomisation for both parents and guardians and patients aged 16+ no longer include the statements that permitted the substitution of vindesine with vincristine in the GPOH N5 course as the sponsor withdrew this substitution in Dec-2023.
Patient Information Flyer
In Mar-2023 we published a series of videos explaining about treatment for High-Risk Neuroblastoma and the HR-NBL2 study on the trial website. To improve patient accessibility and dissemination, a patient-facing flyer has been created for distribution to patients. The flyer is to be made available at the investigators' discretion in combination with the patient information sheets for the trial.