Definition for the Assessment of Time-to-event Endpoints in CANcer Trials (DATECAN-1) (DATECAN-1)

Definition for the Assessment of Time-to-event Endpoints in CANcer Trials (DATECAN-1) : Formal Consensus Method for the Development of Guidelines for Standardized Time-to-event Endpoints' Definitions in Cancer Clinical Trials

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.

We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner.

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).

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Sarcoma and GIST; Other: Breast cancer; Other: Pancreatic cancer; Other: Renal cell carcinoma; Other: Colon cancer; Other: Solid tumours undergoing image-guided tumor ablation

Detailed Description

There is no methodology to provide appropriate definitions for survival endpoints. As such, including or excluding an event in a survival endpoint definition is only based on opinion from experts. For this reason, we launched the DATECAN-1 project in 2009. Its objective is to elaborate standardized definitions for survival endpoints in randomized clinical trials, based on a rigorous and validated consensus methodology. Once this project will be finalized (2012), guidelines for the definitions of survival endpoints to be used in clinical trials will be available.

This collaborative work involves the network of the statisticians from Regional Comprehensive Cancer Centers (Bordeaux, Lille, Montpellier, Dijon, Paris, Toulouse), the network of the Cancer Data Centers (CTD) of the French National Cancer Institute (INCA; Montpellier, Bordeaux, Curie, Dijon-GERCOR) as well as the Headquarters from the European Organization for Research and Treatment of Cancer (EORTC). This project is supported by a 2009 grant from the French League Against Cancer .

The DATECAN-1 project relies on a validated formal consensus method (Fitch K. The Rand/UCLA appropriateness method user's manual. 2001). This consensus approach formalizes the degree of agreement among experts by identifying and selecting the points on which experts agree, disagree or are undecided. The guidelines are subsequently based on agreement points. It is a rigorous and explicit method since it involves international experts in clinical trials in the field of the targeted cancer localizations. This method involves two rounds of rating (questionnaires) and an in-person meeting to address points for which consensus has not been reached yet.

We published the methodology of the consensus process (Bellera et al. Eur J Cancer 2013).

Guidelines have now been published following the international consensus process, for pancreatic cancer, sarcoma and GIST, beast cancer and renal cell carcinoma (See "Citations filed" below). For other localization (head and neck, stomach, colon): guidelines are ongoing.

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Dijon, France
    • Centre Georges Francois Leclerc
  • Montpellier, France
    • Institut du Cancer de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

No patient will be included.

Description

Inclusion Criteria:

• Sarcoma / GIST
• Breast cancer
• Pancreatic cancer
• Renal cell carcinoma
• adjuvant colon cancer

Exclusion Criteria :

- Individual patient data unavailable

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sarcoma and GIST; Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with Sarcoma and GIST	Other: Sarcoma and GIST; No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Breast cancer; Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with Breast cancer	Other: Breast cancer; No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Pancreatic cancer; Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with Pancreatic cancer	Other: Pancreatic cancer; No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Renal cell carcinoma; Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with Renal cell carcinoma	Other: Renal cell carcinoma; No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Colon Cancer (adjuvant setting); Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with Colon Cancer (adjuvant setting)	Other: Colon cancer; No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy (adjuvant setting).
Solid tumours undergoing image-guided tumor ablation; Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with Solid tumours undergoing image-guided tumor ablation	Other: Solid tumours undergoing image-guided tumor ablation; No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Outcomes Defined Following the Consensus Process	Number of time-to-event outcomes defined following the consensus process	1 year after the consitution of the panel of experts

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: National Cancer Institute, France; Institut du Cancer de Montpellier - Val d'Aurelle; Centre Georges Francois Leclerc

Publications and helpful links

General Publications

• Puijk RS, Ahmed M, Adam A, Arai Y, Arellano R, de Baere T, Bale R, Bellera C, Binkert CA, Brace CL, Breen DJ, Brountzos E, Callstrom MR, Carrafiello G, Chapiro J, de Cobelli F, Coupe VMH, Crocetti L, Denys A, Dupuy DE, Erinjeri JP, Filippiadis D, Gangi A, Gervais DA, Gillams AR, Greene T, Guiu B, Helmberger T, Iezzi R, Kang TW, Kelekis A, Kim HS, Kroncke T, Kwan S, Lee MW, Lee FT, Lee EW Jr, Liang P, Lissenberg-Witte BI, Lu DS, Madoff DC, Mauri G, Meloni MF, Morgan R, Nadolski G, Narayanan G, Newton I, Nikolic B, Orsi F, Pereira PL, Pua U, Rhim H, Ricke J, Rilling W, Salem R, Scheffer HJ, Sofocleous CT, Solbiati LA, Solomon SB, Soulen MC, Sze D, Uberoi R, Vogl TJ, Wang DS, Wood BJ, Goldberg SN, Meijerink MR. Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative. Radiology. 2021 Dec;301(3):533-540. doi: 10.1148/radiol.2021203715. Epub 2021 Sep 28.
• Bellera CA, Penel N, Ouali M, Bonvalot S, Casali PG, Nielsen OS, Delannes M, Litiere S, Bonnetain F, Dabakuyo TS, Benjamin RS, Blay JY, Bui BN, Collin F, Delaney TF, Duffaud F, Filleron T, Fiore M, Gelderblom H, George S, Grimer R, Grosclaude P, Gronchi A, Haas R, Hohenberger P, Issels R, Italiano A, Jooste V, Krarup-Hansen A, Le Pechoux C, Mussi C, Oberlin O, Patel S, Piperno-Neumann S, Raut C, Ray-Coquard I, Rutkowski P, Schuetze S, Sleijfer S, Stoeckle E, Van Glabbeke M, Woll P, Gourgou-Bourgade S, Mathoulin-Pelissier S. 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)dagger. Ann Oncol. 2015 May;26(5):865-872. doi: 10.1093/annonc/mdu360. Epub 2014 Jul 28.
• Bonnetain F, Bonsing B, Conroy T, Dousseau A, Glimelius B, Haustermans K, Lacaine F, Van Laethem JL, Aparicio T, Aust D, Bassi C, Berger V, Chamorey E, Chibaudel B, Dahan L, De Gramont A, Delpero JR, Dervenis C, Ducreux M, Gal J, Gerber E, Ghaneh P, Hammel P, Hendlisz A, Jooste V, Labianca R, Latouche A, Lutz M, Macarulla T, Malka D, Mauer M, Mitry E, Neoptolemos J, Pessaux P, Sauvanet A, Tabernero J, Taieb J, van Tienhoven G, Gourgou-Bourgade S, Bellera C, Mathoulin-Pelissier S, Collette L. 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). Eur J Cancer. 2014 Nov;50(17):2983-93. doi: 10.1016/j.ejca.2014.07.011. Epub 2014 Sep 22.
• Bellera CA, Pulido M, Gourgou S, Collette L, Doussau A, Kramar A, Dabakuyo TS, Ouali M, Auperin A, Filleron T, Fortpied C, Le Tourneau C, Paoletti X, Mauer M, Mathoulin-Pelissier S, Bonnetain F. 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. Eur J Cancer. 2013 Mar;49(4):769-81. doi: 10.1016/j.ejca.2012.09.035. Epub 2012 Nov 2.
• Gourgou-Bourgade S, Cameron D, Poortmans P, Asselain B, Azria D, Cardoso F, A'Hern R, Bliss J, Bogaerts J, Bonnefoi H, Brain E, Cardoso MJ, Chibaudel B, Coleman R, Cufer T, Dal Lago L, Dalenc F, De Azambuja E, Debled M, Delaloge S, Filleron T, Gligorov J, Gutowski M, Jacot W, Kirkove C, MacGrogan G, Michiels S, Negreiros I, Offersen BV, Penault Llorca F, Pruneri G, Roche H, Russell NS, Schmitt F, Servent V, Thurlimann B, Untch M, van der Hage JA, van Tienhoven G, Wildiers H, Yarnold J, Bonnetain F, Mathoulin-Pelissier S, Bellera C, Dabakuyo-Yonli TS. 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). Ann Oncol. 2015 Dec;26(12):2505-6. doi: 10.1093/annonc/mdv478. Epub 2015 Oct 13. No abstract available.
• 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 PJ, 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; DATECAN Renal Cancer group. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN projectdagger. Ann Oncol. 2015 Dec;26(12):2392-8. doi: 10.1093/annonc/mdv380. Epub 2015 Sep 14.
• Cohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, Rousseau B, Alberts S, Aparicio T, Boukovinas I, Gill S, Goldberg RM, Grothey A, Hamaguchi T, Iveson T, Kerr R, Labianca R, Lonardi S, Meyerhardt J, Paul J, Punt CJA, Saltz L, Saunders MP, Schmoll HJ, Shah M, Sobrero A, Souglakos I, Taieb J, Takashima A, Wagner AD, Ychou M, Bonnetain F, Gourgou S, Yoshino T, Yothers G, de Gramont A, Shi Q, Andre T; ACCENT Group. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2009
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Randomized controlled trial; Consensus; Endpoint
• Other Study ID Numbers: IB2009-DATECAN-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO