Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials

INTRODUCTION: In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. METHODS: We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner. RESULTS: Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). DISCUSSION: The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results.

Contributors

Bellera, C. A. Pulido, M. Gourgou, S. Collette, L. Doussau, A. Kramar, A. Dabakuyo, T. S. Ouali, M. Auperin, A. Filleron, T. Fortpied, C. Le Tourneau, C. Paoletti, X. Mauer, M. Mathoulin-Pelissier, S. Bonnetain, F.

Publication

Journal: Eur J Cancer
Volume: 49
Issue: 4
Pages: 769 - 81
Year: 2013
DOI: http://dx.doi.org/10.1016/j.ejca.2012.09.035

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s): This research project is funded by a research grant from La Ligue Nationale Contre le Cancer and is also endorsed by the European Organization for Research and Treatment of Cancer (EORTC) and the French National Cancer Institute (INCa). The sponsor had no role in the design of the study, analysis of data or drafting of the manuscript.

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Method(s)

- Consensus meeting
- Delphi process
- Literature review

Linked Studies

• 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)
• Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)
• Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)
• Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN

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