Summary of Changes
- Inclusion and exclusion criteria
- Objectives
- Guidelines regarding dose modification of IMPs
- Guidelines regarding dose of IMPs to be administered (stratum 3)
- Volume of IMP administration (Methotrexate and Carboplatin)
- Hydration guidelines regarding Cisplatin administration
- Radiotherapy guidelines
- Supportive treatments & Concomitant medications
- MRI time point Assessment of Response to Treatment
- Hearing – PTA Dose Modification
- Endocrine evaluation
- Biological material needed for BIOMECA studies
- Planned interim analysis and stopping rules (Stratum 2)
- Adverse Events reporting
- Withdrawal from trial treatment
- Withdrawal of consent to data collection
- Valproate PK/PD studies
MHRA approval [.pdf]
Notification of a substantial amendment [.pdf]
VHP approval [.pdf]
Bfarm request for changes [.pdf]
Sponsor answer to Bfarm [.pdf]