Summary of Changes
Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators.
Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5.
Amendment to exclusion criteria in Trial Synopsis and section 4.2.
Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up.
Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1.
Option to fax emergency randomisation removed. Telephone only in section 6.2
Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age.
Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2.
Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1
Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4.
Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates.
Changes to section 9.1 regarding reporting of laboratory adverse events.
Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11.
Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3.
Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3.
Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1.
Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6
Addition of Trial Management Group meeting frequency in section 14.4.
Changes to the wording of irinotecan randomisation in section 13.4.2.
Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11.
Reference to the National Coordinating Centres has been changed to National Co-Sponsor throughout.
Reference to Sponsor has been changed to Coordinating Sponsor.
- SA-03 Notification of a Substantial Amendment [pdf]
- SA-03 MHRA Approval [pdf]
- SA-03 REC Approval [pdf]
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