N/A
Completed N=2,846
Variability of Definitions for Survival Endpoints and Surrogate Properties for OS in Sarcoma Trials: a Meta-analysis
Source: ClinicalTrials.gov NCT02873923 ↗Enrolled (actual)
2,846
Serious AEs
—
Results posted
Dec 2020
Primary outcomePrimary: Overall Survival — 1704 Participants
Summary
The DATECAN-2 project aims at assessing the surrogate properties for OS of several time-to-event endpoints through meta-analyses of completed and published randomized controlled trials. Two main cancer localization are concerned: breast cancer and soft-tissue sarcomas. The impact of survival endpoints' definitions on the trials' results and conclusions will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
1704 | — |
| SECONDARY Progression-free Survival |
2303 | — |
Eligibility Criteria
No patient will be included.
This project concern Phase III clinical trials with following criteria :
Inclusion Criteria
- Phase III clinical trials that included overall survival (OS) as endpoint and another time-to-event endpoint as primary or secondary endpoint
- Phase III clinical trials that included patients with metastatic soft tissue sarcoma
Data sourced from ClinicalTrials.gov (NCT02873923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.