METASARC: Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa

Sarcoma Clinical Trial

— METASARC  

Official title:

Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977818
• Other study ID #: IB2017-METASARC
• Status: Completed
• Start date: January 1, 1990
• Est. completion date: January 1, 2017

Study information

• Verified date: December 2020
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals. The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug. Outcome (time-to-next treatment [TNT] and overall survival [OS]) will be reported according to histological subtype, as well as the association between TNT and OS. Prognostic factors of OS will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2165
• 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

Inclusion Criteria:

• advanced soft tissue sarcoma
• age > 18 Exclusion Criteria: -

Related Conditions & MeSH terms

• Chemotherapy
• Metastases
• Sarcoma

Locations

Country	Name	City	State
France	Institut Bergonié, Comprehensive Cancer Center	Bordeaux
France	Centre Léon Bérard, Comprehensive Cancer Center	Lyon
France	Institut Gustave Roussy, Comprehensive Cancer Center	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	French Sarcoma Group

Country where clinical trial is conducted

France, 

References & Publications (1)

Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honoré C, Sargos P, Sunyach MP, Le Péchoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment	TNT: time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.; OS: time from the systemic treatment onset to death	2 years