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

Study acronym: DATECAN-1
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Enrollment target: 196 to 265v8 Show 4 more changesShow less
    • Study completion date: Dec 2023 to Dec 2026
    • Interventions: Breast cancer (Other), Colon cancer (Other), Pancreatic cancer (Other), Renal cell carcinoma (Other), Sarcoma and GIST (Other), Solid… to (early) Non Small Cell Lung Cancer (Other), Breast cancer (Other), Colon cancer (Other), Pancreatic cancer (Other), Renal cell carcinoma…
    • Eligibility criteria expanded, about 6 words
    • Study arms: 6 to 7
  2. Results first posted: Feb 8, 2023v7 Show 7 more changesShow less
    • Primary endpoints: 2 to 1
    • Enrollment target: 196
    • Primary completion date changed from estimate of Dec 2020 to Jan 2015
    • Study completion date: Dec 2021 to Dec 2023
    • Interventions: Breast cancer (Other), Colon cancer (Other), Pancreatic cancer (Other), Renal cell carcinoma (Other), Sarcoma and GIST (Other) to Breast cancer (Other), Colon cancer (Other), Pancreatic cancer (Other), Renal cell carcinoma (Other), Sarcoma and GIST (Other), Solid…
    • Secondary endpoints shortened, about 15 words
    • Publications: 6 to 7
  3. Publications: 5 to 6
    • Eligibility criteria expanded, about 3 words
    v6
  4. Primary completion date: Sep 2019 to Dec 2020
    • Study completion date: Sep 2020 to Dec 2021
    • Study arms: 5 to 6
    v5
  5. Study completion date: Sep 2019 to Sep 2020
    • Interventions: Breast cancer (Other), Pancreatic cancer (Other), Renal cell carcinoma (Other), Sarcoma and GIST (Other) to Breast cancer (Other), Colon cancer (Other), Pancreatic cancer (Other), Renal cell carcinoma (Other), Sarcoma and GIST (Other)
    • Study description shortened, about 8 words
    • Study arms: 4 to 5
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study description expanded, about 7 words
    • Publications: details revised at 5 of 5 entries
    v3
  2. Study description shortened, about 17 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03676010
Lead Sponsor Institut Bergonié
Collaborators: National Cancer Institute, France, Institut du Cancer de Montpellier - Val d'Aurelle, Centre Georges Francois Leclerc
Conditions
(from sponsor)		 Cancer
Related terms Neoplasms
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov