Folprecht, Gunnar
,
Trautmann, Karolin
Stein, Alexander
Huebner, Gerdt
Stahl, Michael
Kasper, Stefan
Kretzschmar, Albrecht
Köhne, Claus-Henning
Grünwald, Viktor http://orcid.org/0000-0003-2083-7687
Hofheinz, Ralf-Dieter
Schütte, Katharina
Löffler, Harald
Bokemeyer, Carsten
Krämer, Alwin
Funding for this research was provided by:
Merck KGaA
Arbeitsgemeinschaft Internistische Onkologie (AIO), CUP working group
Article History
Received: 25 May 2020
Revised: 1 October 2020
Accepted: 15 October 2020
First Online: 25 November 2020
Ethics approval and consent to participate
: The legal sponsor of the study was the University of Heidelberg, Germany. The study protocol was approved by the ethics committee of the University of Heidelberg, Germany (leading ethics committee in Germany for this trial, reference number AFmu-408/2008) and by the responsible local ethics committees of all participating centres (ethics committees of the Technische Universität Dresden, Medizinische Hochschule Hannover, Medizinische Fakultät für Klinische Medizin Mannheim der Ruprecht-Karls-Universität Heidelberg, Ärztekammer Schleswig-Holstein, Ärztekammer Niedersachsen, Land Berlin am Landesamt für Gesundheit und Soziales Berlin, Landesärztekammer Rheinland-Pfalz, Universität Ulm, Ärztekammer Nordrhein, Medizinische Fakultät der Universität Düsseldorf-Essen, Universität Regensburg, Ärztekammer Hamburg, Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster and Medizinische Fakultät der Ludwig-Maximilians-Universität München—all Germany). The trial was performed in accordance with the Declaration of Helsinki. All patients provided written informed consent.
: Not applicable.
: Access to the anonymised dataset can be requested from the corresponding author.
: G.F. received a study grant by Merck and honoraria for lectures and advisory board meetings from Merck, Roche, Amgen, Lilly, Sanofi-Aventis, Servier, Bayer, BMS and MSD. K.T. received honoraria for lectures and advisory board meetings from BMS, Celgene, Takeda, GSK, Servier and Janssen-Cilag. A.S. received research grants from Merck, BMS, Roche, Sanofi, Servier, German Cancer Aid and Federal Joint Committee, and honoraria for lectures and advisory board meetings by Merck, Roche, Amgen, Lilly, Sanofi-Aventis, Servier, Bayer, BMS, MSD and Sirtex. G.H. received honoraria for lectures and advisory board meetings by BMS, Sanofi-Aventis, Novartis, Roche and Boehringer Ingelheim. M.S. received honoraria for lectures from Merck and Amgen. SK received financial support for conduction of clinical trials by Merck, BMS; Roche, Celgene and Lilly and received honoraria for lectures and advisory board meetings from Merck, Roche, Amgen, Lilly, Sanofi-Aventis, Servier, Bayer, BMS, MSD and GSK. A.K.R.E. received honoraria for lectures and advisory board meetings or travel support for medical conference attendance by Merck, Roche, Amgen, Sanofi-Aventis, Servier, BMS and MSD. C.H.K. received a study grant and honoraria for lectures and advisory board meetings from Merck, Roche, Amgen, Lilly, Sanofi-Aventis, Servier, Bayer, BMS, MSD and Novartis. V.G. acted as an advisor for BMS, MSD, Merck Serono, AstraZeneca, Novartis, Pfizer, Ipsen, Cerulean, EUSA-Pharm., Roche and Nanobiotix and received compensation for lectures from BMS, MSD, Merck Serono, AstraZeneca, Novartis, Pfizer, Ipsen, Eisai, Roche, PharmaMar, Lilly, Janssen-Cliag and Exelexis. He received research grants from AstraZeneca, BMS, MSD, Pfizer and Ipsen. C.B. received honoraria for lectures and advisory board meetings from Lilly, Merck, Sanofi, Roche Mundipharma, Bayer, Hexal, GSO, BMS, Servier, Pfizer and AstraZeneca. A.K.R.Ä. received research support by Bayer and Merck Serono, study grants by Merck and BMS and honoraria for lectures and advisory board meetings, as well as reimbursement for study-related travels by Roche and Daiichi-Sankyo. All other authors declare no conflict of interest.
: The trial was supported by the German Arbeitsgemeinschaft für Internistische Onkologie (AIO), CUP working group and by an unrestricted grant and provision of cetuximab by Merck-Serono GmbH, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Open Access funding enabled and organized by Projekt DEAL.