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Article History

Received: 13 September 2019

Revised: 26 December 2019

Accepted: 17 January 2020

First Online: 4 February 2020

Ethics approval and consent to participate

: The study was done in accordance with the Declaration of Helsinki. The study was approved by the Committee for the Protection of Persons Ile-de France VIII on 12/07/2011. <i>Reminder of regulatory texts currently in force</i>: This trial will be conducted in accordance with the New European Directive 2001/20/EC. <i>Civil liability insurance</i>: An insurance policy was taken out by the sponsor with SHAM under contract number 137681 (Appendix 10), in accordance with article L 1121-10 of the Public Health Code. <i>Request for CPP and AFSSAPS authorisation</i>: This protocol has received approval from the CPP [Comité de Protection des Personnes] (Medical Ethics Committee) Ile-de-France VIII (Boulogne A. Paré) on 12/07/2011. This protocol has been authorised by the AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) (French Health Products Safety Agency) on 25/07/2011. <i>Obtaining the patient's consent</i>: The investigator undertakes to obtain the patient's consent for the clinical and biological studies in writing, after providing adequate information. A copy of these consent forms must be kept by the investigator for 15 years, to be presented to the governing authorities in case of an inspection. The original is given to the patient. <i>Informing hospital managements and research agreement</i>: Before starting the study, hospital managements will be informed by the sponsor of the investigator's interest in taking part in this trial. A research contract without additional cost will be drawn up between the study centre manager and the sponsor.

: Not applicable.

: Data supporting this publication are stored at the FFCD Data Center.

: Pr Aparicio reports personal grants; consultancy for BMS: payments for development of educational presentations for Ipsen Pharma Roche, Servier, Amgen; travel grants from Ipsen Pharma, Roche, Bayer. Pr Ghiringhelli reports personal grants consultancy for Roche, AstraZeneca; payments for development of educational presentations for Roche, Servier, Amgen, Merck; MSD: travel grants from Amgen, Servier, Roche. Pr Bouché reports personal grants consultancy for Roche, Merck, Amgen; payments for development of educational presentations for Bayer, Pierre Fabre, Servier, Amgen; travel grants from Lilly, Roche, Bayer. Pr Bachet reports personal grants consultancy for Amgen, AstraZeneca, Bayer, Merck Serono, Pierre Fabre and Servier; payments for development of educational presentations for Amgen, AstraZeneca, Bayer, Merck Serono, Mundipharma, Pierre Fabre, Roche, Sanofi and Servier; travel grants from Amgen, Bayer, Merck Serono, Roche, Sanofi and Servier. Dr. Cojocarasu reports payment for board participation from Sanofi; travel grants from Amgen, Roche and Pfizer. Dr. Boige reports grants, personal fees and non-financial support from Merck Serono, Bayer, Amgen, Sanofi, Daiichi Sankyo, Novartis, Roche and Prestizia, outside the submitted work. Pr Taieb reports personal grants for consultancy for Abbvie, Amgen, Baxalta, Celgene, Lilly, Merck and Roche; payment for lectures including service on speaker’s bureau for ABBVIE, Amgen, Celgene, Lilly, Merck and Roche; payments for development of educational presentations for Roche and travel grants from Roche and Merck. Pr Phelip reports personal grants for board membership for Roche, Sanofi, Lilly Merck and Amgen; consultancy for Lilly and Roche; payments for development of educational presentations for Roche, Sanofi, Lilly Merck and Amgen. Pr Phelip reports grants for his institution for board membership for Roche and Merck; payments of grants from Merck and Roche. Dr. François reports personal grants for board membership for Roche, Merck and Sanofi. Dr. Faroux reports personal grants for clinical research for Merck; payment for lectures and consultancy for Amgen, Merck and Roche; travel grants from Amgen, Celgene, Merck and Roche. Pr Lepage reports personal grants for board membership for AAA, grants from Novartis and travel grants from Ipsen pharma, Amgen and Bayer. Dr. Bennouna reports personal grants for board membership for Roche, Boehringer-Ingelheim, AstraZeneca, Servier and BMS; payment for lectures including service on speaker’s bureau for Roche and AstraZeneca, and travel grants from Roche and BMS. Pr Dahan reports personal grants for clinical research for Ipsen, Lilly, MSD and Sanofi; for payment for lectures and consultancy for Amgen, Baxalta, Celgene, Lilly, Merck, Sanofi and Roche; travel grants from Celgene, Ipsen and Sanofi. No other disclosures are reported.

: The study was funded by Fédération Francophone de Cancérologie Digestive (FFCD). ROCHE provided financial support for study management. The study was sponsored by “Fédération Francophone de Cancérologie Digestive” (FFCD), which was responsible for the study management for design and conduct of the study; for collection, management, analysis and interpretation of the data; for preparation, review or approval of the paper; for decision to submit the paper for publication.