Chemotherapy, Metastases, Sarcoma
Conditions
Keywords
outcome, time to next treatment, overall survival, patterns of care
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.
Interventions
None listed
Sponsors
French Sarcoma Group
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* advanced soft tissue sarcoma * age \> 18
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment | 2 years | 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013 Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria | 2,165 |
| Total | 2,165 |
Baseline characteristics
| Characteristic | Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013 |
|---|---|
| Age, Customized Age < 75 years | 1886 Participants |
| Age, Customized Age >= 75 years | 279 Participants |
| Region of Enrollment France | 2165 participants |
| Sex: Female, Male Female | 1110 Participants |
| Sex: Female, Male Male | 1055 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,165 |
| serious Total, serious adverse events | 0 / 2,165 |
Outcome results
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
Time frame: 2 years
Population: Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013 | Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment | 0.76 correlation coefficient |