Cancer Clinical Trial
— DATECAN-2Official title:
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
Verified date | December 2020 |
Source | Institut Bergonié |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2846 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institut Bergonié | Centre Georges Francois Leclerc, Institut du Cancer de Montpellier - Val d'Aurelle, Ligue contre le cancer, France, National Cancer Institute, France |
Savina 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. — View Citation
Savina M, Litière 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-Pélissier S, Bellera C. Surrogate en — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Number of deaths | up to 18 months following randomization | |
Secondary | Progression-free Survival | 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 | Up to 12 months following randomization |
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