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Article History

Received: 17 June 2020

Accepted: 26 July 2020

First Online: 8 August 2020

Ethics approval and consent to participate

: Ethical approval for the study was granted by the responsible Ethics Committee of the State Chamber of Medicine in Rheinland-Pfalz and the local Ethics Committee of the Chamber of Medicine Westfalen-Lippe responsible for the participating study center. The study was further approved by the national competent authority, the Federal Institute for Drugs and Medical Devices (BfArM). The complete details of all involved authorities can be found in Additional file . The trial is planned and conducted in line with the principles of the Declaration of Helsinki (latest amendment), the standards of ICH-GCP (topic E6), the GCP-V, the AMG and the BDSG. In addition, the clinical trial office, the division of data protection, quality management and the legal department of the German Cancer Research Center reviewed the entire planning phase of the study. The trial was registered in the German Clinical Trials Register “DRKS” (DRKS00019907) before the first patient was recruited. All participants provide written informed consent before enrollment in the VICTORIA trial. The protocol is the 3rd edition as of March 30, 2020.

: Not applicable.

: The authors declare that they have no competing interests.