Funding for this research was provided by:
Deutsche Krebshilfe (70112026)
Received: 11 August 2020
Accepted: 8 September 2020
First Online: 15 September 2020
Ethics approval and consent to participate
: The RACE trial protocol was submitted to and received ethics approval by the lead ethics committee, the Ethics Committee II of the University of Heidelberg on September 24th 2019. The study will be performed according to current legal standards. The ICH E6 R2 Harmonised Tripartite Guideline for Good Clinical Practice will be taken into account as well as the current version of the Declaration of Helsinki. In Germany, the requirements according to Deutsches Arzneimittelgesetz (AMG) will be fulfilled. The study will comply with all local regulatory requirements for data protection, especially the EU-DSGVO (Datenschutzgrundverordnung, General Data Protection Regulation). The Ruprecht Karls-University of Heidelberg is the sponsor of the study with respect to GCP regulations (according to article 7 of the EC Commission Directive 2005/28/EC), as the trial at hand is a non-commercial or investigator-initiated clinical trial. The RACE trial has been registered in the EudraCT registry (EudraCT number: 2018–001728-20) and in NCT04375605.
: Not applicable.
: The authors declare that they have no competing interests.