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.
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 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.
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.
- SA-02 Notification of a Substantial Amendment [pdf]
- SA-02 BEACON ionising radiation [pdf]
- SA-02 Note to file 04Apr2013 [pdf]
- SA-02 REC Cover letter 08Mar2013 [pdf]
- SA-02 REC Approval 02Apr2013 [pdf]
- SA-02 Updated REC Form with highlighted changes [pdf]