Clinical trial · Observational
Variability of Definitions for Survival Endpoints and Surrogate Properties for OS in Sarcoma Trials: a Meta-analysis
Survival Endpoints in Randomized Clinical Trials in Sarcoma Patients: Meta-analyses for the Assessment of the Impact Various Definitions on Trials' Results and of Surrogate Properties for OS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| undefined | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with a metastatic soft tissue sarcoma
- description
- All patients included in eligible clinical trials of the meta-analysis
- interventionNames
- Drug: undefined
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- up to 18 months following randomization
- description
- Number of deaths
Secondary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Up to 12 months following randomization
- description
- Number of progressions or deaths. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTSavina M, Gourgou S, Italiano A, Dinart D, Rondeau V, Penel N, Mathoulin-Pelissier S, Bellera C. Meta-analyses evaluating surrogate endpoints for overall survival in cancer randomized trials: A critical review. Crit Rev Oncol Hematol. 2018 Mar;123:21-41. doi: 10.1016/j.critrevonc.2017.11.014. Epub 2017 Nov 23. PMID 29482777
- RESULTSavina M, Litiere S, Italiano A, Burzykowski T, Bonnetain F, Gourgou S, Rondeau V, Blay JY, Cousin S, Duffaud F, Gelderblom H, Gronchi A, Judson I, Le Cesne A, Lorigan P, Maurel J, van der Graaf W, Verweij J, Mathoulin-Pelissier S, Bellera C. Surrogate endpoints in advanced sarcoma trials: a meta-analysis. Oncotarget. 2018 Oct 2;9(77):34617-34627. doi: 10.18632/oncotarget.26166. eCollection 2018 Oct 2. PMID 30349653