Update to Main Study Patient Information Sheets
A substantial amendment was made to the Main Study Patient Information Sheets (PIS) (ages 13years and above and Parent/Guardian) to make the wording appropriate for patients irrespective of whether they are recruited at sites that are open to all three randomisations (induction chemothrapy (R-I), high-dose chemotherapy (R-HDC) and radiotherapy (R-RTx)) or only to the two chemotherapy randomisations. The change was made to enable sites to open and begin recruiting patients before their radiotherapy arrangements are fully set up, enabling recruitment rates in the UK to improve. The international sponsor had given agreement for this where it would enable a site to open to recruitment sooner because only 10% of patients would be expected to be eligible to participate in R-RTx if it were available and because most of the sites this amendment allows to open would be expected to have R-RTx in place by the time any patents they recruit require radiothearpy.