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Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

par Bonnetain, Franck;Bonsing, Bert;Conroy, Thierry;Dousseau, Adelaide;Glimelius, Bengt;Haustermans, Karin;Lacaine, François;Van Laethem, Jean-Luc ;Aparicio, Thomas;Aust, Daniela D.E.;Bassi, Claudio;Berger, Virginie;Chamorey, Emmanuel;Chibaudel, Benoist;Dahan, Laeticia;de Gramont, Aimery;Delpero, Jean Robert;Dervenis, Christos;Ducreux, Michel;Gal, Jocelyn;Gerber, Erich;Ghaneh, Paula;Hammel, Pascal;Hendlisz, Alain ;Jooste, Valérie;Labianca, Roberto;Latouche, Aurelien;Lutz, Manfred B.;Macarulla, Teresa;Malka, D;Mauer, Murielle;Mitry, Emmanuel;Neoptolemos, John;Pessaux, Patrick;Sauvanet, Alain;Tabernero, Josep;Taieb, Julien;Van Tienhoven, Geertjan;Gourgou-Bourgade, Sophie;Bellera, Carine;Mathoulin-Pélissier, Simone;Collette, Laurence
Référence European journal of cancer, 50, 17, page (2983-2993)
Publication Publié, 2014-11

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Résumé :

Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer.