NSA-01

Summary of Changes

Sections of the protocol which refer to administration of chemotherapy have been amended to align them with current UK practice and to clarify the text as described below. Please note, the doses of the drugs have not changed.

Vincristine is routinely given as an IV bolus but in version 2.0 it was listed in the table of IMPs in paras. 7.1.1; 7.2.1 and 7.3.1. as an infusion. However, all the tables of doses and associated text referred to an IV bolus (paras. 7.1.3; 7.2.3; 7.2.6; 7.3.2.1.). This has been amended in version 2.1.
The etoposide dosage volume in version 2.0 is different from UK practice. The Protocol states Etoposide 100mg/m2 in 100-150ml/m2 of saline and administered over 1 hour. This is 1-0.67mg/ml and in the UK the maximum accepted final concentration of Etoposide is 0.4mg/ml. with an infusion time of up to 4 hours. This has been amended in version 2.1.
Version 2.0 of the protocol states that hydration should contain calcium gluconate 0.6mmol/l – however in the UK the nationally accepted hydration bag contains calcium chloride 0.6mmol/l. These sections have been amended in version 2.1.
The dose of Cyclophosphamide below the ‘VEC’ table para. 7.2.3. for patients < 10kg has been amended to show 3 divided infusions over 60 minutes ie 33mg/kg/infusion .
Page 97 of version 2.0 of the protocol states that Mesna doses should be 120% of Cyclophosphamide and to infuse Mesna at 1500mg/m2 however this would be 100% of cyclophosphamide. It should be 1800mg/m2. This has been amended in version 2.1.

The following document is attached:

Email from the Sponsor stating that this is to be regarded as a non-substantial amendment (email dated 26^th June 2015).