An observational study in Cancer, sponsored by Institut Bergonié. Active, not recruiting at 3 sites in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Institut Bergonié · Observational
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 265 is above the median of 205 across 1,680 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
No patient will be included.
Exclusion Criteria :
- Individual patient data unavailable
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
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
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
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
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
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
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 (early) Non Small Cell Lung Cancer
Other: (early) Non Small Cell Lung Cancer
No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
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).
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
Number of Outcomes Defined Following the Consensus Process
Number of time-to-event outcomes defined following the consensus process
Time frame: 1 year after the consitution of the panel of experts
| Milestone | Sarcoma and GIST | Breast Cancer | Pancreatic Cancer | Renal Cell Carcinoma | Colon Cancer (Adjuvant Setting) | Solid Tumours Undergoing Image-guided Tumor Ablation | (Early) Non Small Cell Lung Cancer |
|---|---|---|---|---|---|---|---|
| Started | 32 | 35 | 33 | 36 | 24 | 36 | 69 |
| Completed | 28 | 31 | 30 | 31 | 24 | 24 | 54 |
| Not completed | 4 | 4 | 3 | 5 | 0 | 12 | 15 |
Number of time-to-event outcomes defined following the consensus process
| Time to event outcomes | Sarcoma and GIST | Breast Cancer | Pancreatic Cancer | Renal Cell Carcinoma | Colon Cancer (Adjuvant Setting) | Solid Tumours Undergoing Image-guided Tumor Ablation | (Early) Non Small Cell Lung Cancer |
|---|---|---|---|---|---|---|---|
| Number of Outcomes Defined Following the Consensus Process | 12 | 11 | 14 | 7 | 5 | 4 | 19 |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sarcoma and GIST | — | — | — |
| Breast Cancer | — | — | — |
| Pancreatic Cancer | — | — | — |
| Renal Cell Carcinoma | — | — | — |
| Colon Cancer (Adjuvant Setting) | — | — | — |
| Solid Tumours Undergoing Image-guided Tumor Ablation | — | — | — |
| (Early) Non Small Cell Lung Cancer | — | — | — |
| Age, Customized(Participants) | Sarcoma and GIST | Breast Cancer | Pancreatic Cancer | Renal Cell Carcinoma | Colon Cancer (Adjuvant Setting) | Solid Tumours Undergoing Image-guided Tumor Ablation | (Early) Non Small Cell Lung Cancer | Total |
|---|---|---|---|---|---|---|---|---|
| 18 years and older | 28 | 31 | 30 | 31 | 24 | 24 | 54 | 222 |
| Sex: Female, Male(Participants) | Sarcoma and GIST | Breast Cancer | Pancreatic Cancer | Renal Cell Carcinoma | Colon Cancer (Adjuvant Setting) | Solid Tumours Undergoing Image-guided Tumor Ablation | (Early) Non Small Cell Lung Cancer | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 8 | 11 | 10 | 11 | 7 | 8 | 27 | 82 |
| Male | 20 | 20 | 20 | 20 | 17 | 16 | 27 | 140 |
| Race and Ethnicity Not Collected(Participants) | Sarcoma and GIST | Breast Cancer | Pancreatic Cancer | Renal Cell Carcinoma | Colon Cancer (Adjuvant Setting) | Solid Tumours Undergoing Image-guided Tumor Ablation | (Early) Non Small Cell Lung Cancer | Total |
|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Sarcoma and GIST | Breast Cancer | Pancreatic Cancer | Renal Cell Carcinoma | Colon Cancer (Adjuvant Setting) | Solid Tumours Undergoing Image-guided Tumor Ablation | (Early) Non Small Cell Lung Cancer | Total |
|---|---|---|---|---|---|---|---|---|
| France | 6 | 15 | 17 | 11 | 3 | 1 | 8 | 61 |
| Italy | 4 | 1 | 2 | 3 | 3 | 1 | 8 | 22 |
| Denmark | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 4 |
| Belgium | 2 | 5 | 2 | 4 | 0 | 1 | 2 | 16 |
| United States | 6 | 0 | 0 | 3 | 6 | 5 | 9 | 29 |
| Netherlands | 3 | 2 | 1 | 2 | 1 | 5 | 7 | 21 |
| United Kingdom | 2 | 2 | 2 | 6 | 4 | 4 | 3 | 23 |
| Germany | 2 | 0 | 2 | 1 | 1 | 5 | 0 | 11 |
| Poland | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Portugal | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 |
| Slovenia | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Greece | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 3 |
| Spain | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 |
| Austria | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
| Canada | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 3 |
| Japan | 0 | 0 | 0 | 0 | 2 | 1 | 6 | 9 |
| Switzerland | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 3 |
| Australia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Argentina | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 5 |
| India | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Plan to share: No
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Institut Bergonié