Summary of Changes
- Change of treatment for Arm A patients (good risk localised disease) from 8 cycle VAC to 1 cycle VAI plus 7 cycles VAC
- Change of terminology from co-sponsor to national coordinating centre throughout
- Changes to pharmacovigilance reporting requirements
- Inclusion of dose modifications for febrile neutropenia for patients in arm B.
- Updated diagnosis section 8.2.7 and eligibility criteria to include ‘Ewing’s like’ tumours which are EWSR1 negative.
- Change of dose for patients >18yrs receiving zoledronic acid, and change of infusion time.
- Addition of treatment advice for allergic reaction to methylene blue.
- Addition of allowing MRI and CT scans as end of treatment assessment.
- Clarification that lung radiotherapy is only recommended not mandated.
MHRA approval [.pdf]
MHRA cover letter [.pdf]
REC favourable opinion [.pdf]
REC cover letter [.pdf]
Notification of a substantial amendment [.pdf]