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

• ClinicalTrials.gov Identifier: NCT03676010
• Recruitment Status: Active, not recruiting
• First Posted: September 18, 2018
• Last Update Posted: November 27, 2020
• Sponsor: Institut Bergonié
• Collaborators: National Cancer Institute, France; Institut du Cancer de Montpellier - Val d'Aurelle; Centre Georges Francois Leclerc
• Information provided by (Responsible Party): Institut Bergonié

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Cancer	Other: Sarcoma and GIST; Other: Breast cancer; Other: Pancreatic cancer; Other: Renal cell carcinoma; Other: Colon cancer

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 Design

• Study Type: Observational
• Observational Model: Other
• Time Perspective: Other
• Official Title: 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
• Actual Study Start Date: September 2009
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
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	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	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	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)	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

Outcome Measures

Primary Outcome Measures :

1. Disease-specific survival [ Time Frame: 1 year ]
   To be defined by the consensus process
2. Relapse-free survival [ Time Frame: 1 year ]
   To be defined by the consensus process

Secondary Outcome Measures :

1. Loco-regional relapse free survival [ Time Frame: 1 year ]
   To be defined by the consensus process
2. Time to treatment failure [ Time Frame: 1 year ]
   To be defined by the consensus process
3. Time to progression [ Time Frame: 1 year ]
   To be defined by the consensus process
4. Time to local progression [ Time Frame: 1 year ]
   To be defined by the consensus process

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

No patient will be included.

Criteria

Inclusion Criteria:

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

Exclusion Criteria :

- Individual patient data unavailable

Contacts and Locations

Locations

France

Institut Bergonié

Bordeaux, France, 33076

Centre Georges François Leclerc

Dijon, France

Institut du Cancer de Montpellier

Montpellier, France

Sponsors and Collaborators

Institut Bergonié

National Cancer Institute, France

Institut du Cancer de Montpellier - Val d'Aurelle

Centre Georges Francois Leclerc

  Study Documents (Full-Text)

Documents provided by Institut Bergonié:

Study Protocol  [PDF] November 2, 2012

More Information

Publications of Results:

Bellera CA, Penel N, Ouali M, Bonvalot S, Casali PG, Nielsen OS, Delannes M, Litière 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 Péchoux 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-Pélissier 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)†. Ann Oncol. 2015 May;26(5):865-872. doi: 10.1093/annonc/mdu360. Epub 2014 Jul 28. Review.

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-Pélissier 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. Review.

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-Pélissier 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, Thürlimann B, Untch M, van der Hage JA, van Tienhoven G, Wildiers H, Yarnold J, Bonnetain F, Mathoulin-Pélissier 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.

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, Houédé 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 project†. Ann Oncol. 2015 Dec;26(12):2392-8. doi: 10.1093/annonc/mdv380. Epub 2015 Sep 14. Review.

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, André 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.

• Responsible Party: Institut Bergonié
• ClinicalTrials.gov Identifier: NCT03676010
• Other Study ID Numbers: IB2009-DATECAN-1
• First Posted: September 18, 2018
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Institut Bergonié:

Cancer; Randomized controlled trial; Endpoint; Consensus