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Article History

Received: 21 May 2019

Accepted: 15 July 2019

First Online: 19 July 2019

Compliance with ethical standards

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: Ulrich Herrlinger has served as a consultant for Roche, Novocure, Mundipharma, Noxxon, and Bristol-Myers-Squibb. He has received a scientific grant from Roche and speakers honoraria from Roche, Medac and Riemser Pharma. Martin Glas has served as a consultant for Roche, Novartis, Mundipharma, sigma tau, and UCB Corporation. He has received speakers honoraria from Roche, Medac and sigma tau, and a scientific grant from Medac. Niklas Schäfer received speakers honoraria and travel fees from Roche. Sied Kebir received speakers honoraria from Roche and Novocure. Joachim Steinbach has received a grant from Merck as well as honoraria for lectures, travel or advisory board participation from Roche, Boehringer, Bristol-Myers Squibb, Medac and Mundipharma. All other authors declare that they have no conflict of interest.

: GLARIUS was a randomized, controlled, unblinded, phase II trial (EudraCT No. 2009010390-21; ClinicalTrials.gov NCT00967330) approved by ethics committees of all participating centers. All patients gave written informed consent. All trial procedures adhered to the Declaration of Helsinki and the Guidelines of Good Clinical Practice. An independent data monitoring and safety board regularly reviewed all safety-relevant information. Roche Pharmaceuticals funded the trial. Data collection was performed by an independent clinical research organization funded by Roche. The principal investigator (U.H.) had full access to the data, reviewed all data, and had the final responsibility for manuscript submission.