Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project+

Kramar A, Negrier S, Sylvester R, Joniau S, Mulders P, Powles T, Bex A, Bonnetain F, Bossi A, Bracarda S, Bukowski R, Catto J, Choueiri TK, Crabb S, Eisen T, El Demery M, Fitzpatrick J, Flamand V, Goebell P, Gravis G, Houede N, Jacqmin D, Kaplan R, Malavaud B, Massard C, Melichar B, Mourey L, Nathan P, Pasquier D, Porta C, Pouessel D, Quinn D, Ravaud A, Rolland F, Schmidinger M, Tombal B, Tosi D, Vauleon E, Volpe A, Wolter P, Escudier B, Filleron T (2015)

Publication Type: Journal article

Publication year: 2015


Book Volume: 26

Pages Range: 2392-8

Journal Issue: 12

DOI: 10.1093/annonc/mdv380


In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions.A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events.Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression).The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in all RCC clinical trials, thus facilitating reporting and increasing precision in between trial comparisons.

Authors with CRIS profile

Involved external institutions

Centre Hospitalier Universitaire Carémeau FR France (FR) Hôpitaux universitaires de Strasbourg (HUS) / University Hospital Strasbourg FR France (FR) University College London (UCL) GB United Kingdom (GB) Centre Hospitalier Universitaire (CHU) de Toulouse FR France (FR) Institut Gustave-Roussy FR France (FR) Palacky University Olomouc / Univerzita Palackého v Olomouci CZ Czech Republic (CZ) Institut Claudius-Regaud (ICR) UNICANCER FR France (FR) Mount Vernon Cancer Centre GB United Kingdom (GB) Centre Oscar Lambret (UNICANCER) FR France (FR) Policlinico San Matteo Pavia Fondazione IRCCS IT Italy (IT) Assistance Publique-Hôpitaux de Paris (AP-HP) FR France (FR) University of Southern California (USC) US United States (USA) (US) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux FR France (FR) Institut de Cancérologie de l'Ouest FR France (FR) Medizinische Universität Wien AT Austria (AT) Cliniques universitaires Saint-Luc (CHU St-Luc) BE Belgium (BE) Institut régional du Cancer de Montpellier (ICM) FR France (FR) Centre Eugène Marquis FR France (FR) University of Eastern Piedmont / Università degli Studi del Piemonte Orientale "Amedeo Avogadro" IT Italy (IT) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven BE Belgium (BE) Université Claude Bernard Lyon 1 (UCB) FR France (FR) European Organisation for Research and Treatment of Cancer (EORTC) BE Belgium (BE) Radboud University Nijmegen NL Netherlands (NL) Queen Mary University of London GB United Kingdom (GB) Netherlands Cancer Institute (NKI) NL Netherlands (NL) Centre hospitalier régional et universitaire de Besançon (CHRU Besancon) FR France (FR) Gruppo Ospedaliero San Donato IT Italy (IT) Cleveland Clinic US United States (USA) (US) University of Sheffield GB United Kingdom (GB) Dana–Farber Cancer Institute US United States (USA) (US) University of Southampton GB United Kingdom (GB) Cambridge University Hospital GB United Kingdom (GB) Mater Misericordiae University Hospital (MMUH) / Ospidéal an Mater Misercordiae IE Ireland (IE) Université de Lille (ULille) / University of Lille Nord de France / Université Lille Nord de France / Université Lille II FR France (FR) Institute Paoli-Calmettes FR France (FR)

How to cite


Kramar, A., Negrier, S., Sylvester, R., Joniau, S., Mulders, P., Powles, T.,... Filleron, T. (2015). Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project+. Annals of Oncology, 26(12), 2392-8.


Kramar, A., et al. "Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project+." Annals of Oncology 26.12 (2015): 2392-8.

BibTeX: Download