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Article History

Received: 20 June 2019

Accepted: 26 December 2019

First Online: 3 January 2020

Ethics approval and consent to participate

: The study protocol (Version 1.0 v. 20.05.2018), amendments, informed consent form have been reviewed and approved by the sponsor (Technical University Munich, faculty for medicine) and the accredited medical ethics committee of the Technical University Munich and the responsible German government authority Paul-Ehrlich-Institute, Langen, Germany. The Deutsche Gesellschaft für Radioonkologie e.V. (DEGRO) expert committee decided in regard to this study that the use of radiation in this trial is medical care and does not need approval of Bundesamt für Strahlenschutz (BfS).Investigators must ensure that subjects are clearly and fully informed about the purpose, potential risks, and other critical issues regarding clinical studies in which they volunteer to participate. They also have to inform the subjects about handling and use of personal data. The sponsor will provide the site with an appropriate informed consent form which will include all elements required by ICH, GCP and applicable regulatory requirements. The informed consent form will adhere to the ethical principles that have their origin in the Declaration of Helsinki.Investigators must:

: Not applicable.

: SCS received travel grants from Astellas, Janssen-Cilag, Novartis and Bristol-Myers Squibb.MR received consultancy honoraria from Bayer, Bristol-Myers Squibb, Ipsen Pharma, Janssen-Cilag, MSD, Novartis, Pierre Fabre, Pfizer and Roche.JEG received consultancy honoraria from Bayer, Bristol-Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer and Roche.FJK, CR, PM, AS, FB, AS, HK, MF, FC, SEC, KS declare no conflict of interest.