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Article History

Received: 27 May 2019

Accepted: 21 December 2019

First Online: 17 January 2020

Ethics approval and consent to participate

: The trial was initially approved by NRES Committee North West - Greater Manchester Central on 1 February 2013. Since then, there have been 11 approved substantial amendments and the latest version of the protocol (version 5.0) was approved by the ethics committee on 7 August 2017. This latest amendment to protocol version 5.0 was to change the consolidation treatment for patients with poor risk localised disease to VAI plus BuMel, following the results of the earlier trial EURO-E.W.I.N.G. 99 becoming available demonstrating this treatment to be superior. Please note that the dates of ethical approvals are for the submissions made by the coordinating sponsor in the UK; each NCC has to submit to and gain approvals from the relevant regulatory bodies in their country (or countries). Central ethical approval for the whole UK was confirmed by the NRES Committee North West - Greater Manchester Central (reference approval number 12/NW/0827), and we will not begin recruiting at other centres and in other countries until the relevant country-specific and local ethical approval has been obtained.Written informed consent is obtained from each patient or parent/legal guardian (or both) for each randomisation prior to performing any trial-related procedure. At trial entry, the patient or parent/legal guardian or both are also given the option of consenting to the collection, storage and analysis of additional tumour, blood and bone marrow samples for use in biological studies associated with the trial but this does not affect whether they can enter the trial. Patients have the right to withdraw from the study at any time and for any reason without prejudice to their future medical care.With the patient’s consent (and where national legislation/guidance permits), their full name, date of birth, hospital number, medical practitioner details and national registry numbers (e.g., National Health Service Number in the UK) are collected at trial entry to allow long-term follow-up via other health-care professionals (e.g., patient’s medical practitioner) and national cancer registries. Personal data recorded on all documents are regarded as strictly confidential and are handled and stored in accordance with the relevant data protection legislation in the member state. Patients are identified using only their unique trial number and, if national legislation permits, their initials and date of birth on the header section of the eRDC screens and in correspondence between the applicable NCC and participating sites.

: Not applicable.

: The authors declare that they have no competing interests.