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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

265

participants targeted

Target at P75+ for all trials

Timeline

7mo left

Started Sep 2009

Longer than P75 for all trials

Geographic Reach

1 country

3 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

17.3 years study duration

Study Progress97%

Sep 2009Dec 2026

Study Start

First participant enrolled

September 1, 2009

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed

3.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed

4.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed

3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

5.3 years

First QC Date

September 17, 2018

Results QC Date

February 1, 2022

Last Update Submit

November 24, 2025

Conditions

Cancer

Keywords

CancerRandomized controlled trialEndpointConsensus

Outcome Measures

Primary Outcomes (1)

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

Study Arms (7)

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

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

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

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

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

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

(early) Non Small Cell Lung 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 (early) Non Small Cell Lung Cancer

Other: (early) Non Small Cell Lung Cancer

Interventions

Sarcoma and GISTOTHER

No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.

Sarcoma and GIST

Breast cancerOTHER