Document is current

Article History

Received: 2 September 2021

Accepted: 5 December 2021

First Online: 20 December 2021

Declarations

:

: The Heidelberg Committee approved this study (S-204/2019 for Heidelberg, B-F-2021-052 for Stuttgart and positive approval for Marburg/Gießen from 08.05.2020). Consent to participate/informed consent will be obtained from all participants in the study.Central ethical approval has been confirmed from the Heidelberg Committee and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained.

: Not applicable.

: The trial is funded by the German Cancer Aid. All persons involved (including the principal investigator and coordinator) declare that there is no conflict of interest in connection with the implementation and evaluation of the study.Study participation will generally not incur additional costs (compared to standard care) for patients. However, for all sites without the possibility of irradiation with protons, additional travel costs may arise in the event that patients are drawn into the treatment arm with protons and would then possibly have a longer journey to treatment compared to irradiation outside the study. For this purpose, the corresponding travel and, if necessary, accommodation costs are requested from the health insurance company (note: the implementation of such a phase III study was expressly requested by the health insurance companies). The patient will be informed about this.