Variability of Definitions for Survival Endpoints and Surrogate Properties for OS in Sarcoma Trials: a Meta-analysis

NCT02873923 | Completed Results

• 1 other identifier: IB2012-DATECAN-2
• Study Type: observational
• Target: 2,846
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Keywords

clinical trial; surrogate endpoints; meta analysis

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Number of deaths

  up to 18 months following randomization

Secondary Outcomes (1)

• Progression-free Survival

  Up to 12 months following randomization

Study Arms (1)

Patients with a metastatic soft tissue sarcoma

All patients included in eligible clinical trials of the meta-analysis

Drug: undefined

Interventions

undefined DRUG

Chemotherapy drug (meta-analyses of randomized trials)

Patients with a metastatic soft tissue sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in phase III randomized clinical trials assessing patients with metastatic soft-tissue sarcoma

You may qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead
• National Cancer Institute, France: collaborator
• Ligue contre le cancer, France: collaborator
• Institut du Cancer de Montpellier - Val d'Aurelle: collaborator
• Centre Georges Francois Leclerc: collaborator

Related Publications (2)

• 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. doi: 10.1016/j.critrevonc.2017.11.014. Epub 2017 Nov 23.

  PMID: 29482777 RESULT

• Savina 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 RESULT

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr Carine Bellera
• Organization: Institut Bergonié

c.bellera@brodeaux.unicancer.fr

33 5 56 33 04 95

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 22, 2016
• Study Start: October 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 25, 2021
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share