Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa

NCT03977818 | Completed Results

• 1 other identifier: IB2017-METASARC
• Study Type: observational
• Target: 2,165
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sarcoma; Metastases; Chemotherapy

Keywords

outcome; time to next treatment; overall survival; patterns of care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013

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

advanced soft tissue sarcoma

You may qualify if:

• advanced soft tissue sarcoma
• age \> 18

Sponsors & Collaborators

• Institut Bergonié: lead
• French Sarcoma Group: collaborator

Study Sites (3)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

Location

Centre Léon Bérard, Comprehensive Cancer Center

Lyon, France

Location

Institut Gustave Roussy, Comprehensive Cancer Center

Villejuif, France

Location

Related 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, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.

  PMID: 28391775 RESULT

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pr Antoine Italiano
• Organization: Institut Bergonié

a.italiano@bordeaux.unicancer.fr

33 5 56 33 33 33

Study Officials

• Antoine Italiano, MD/PhD

  Institut Bergonié, Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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: May 23, 2019
• First Posted: June 6, 2019
• Study Start: January 1, 1990
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 5, 2025
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)