Resectable, non-metastatic soft-tissue sarcoma (STS)
Conditions
Brief summary
Metastasis progression-free survival (M-PFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014).
Detailed description
Loco-regional relapse-free survival (LR-RFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or loco-regional progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2015). Progression-free survival is defined as the time interval between the randomization date and the date of death (whatever the cause) or progression (as per RECIST v1.1), whichever occurs first., Overall survival is defined as the time interval between the randomization date and the date of death (whatever the cause)., Best overall response is defined as the best response recorded from randomization until the end of neoadjuvant chemotherapy taking into account any requirement for confirmation as per RECIST v1.1 criteria, Histological response is defined based on tumour sample as the average proportion of recognizable cells on the tumour sample [Huvos et al, Arch Pathol Lab Med 1977]. Good histological response is defined as <10% viable cells on the tumour sample., Safety will be described using the common toxicity criteria from the NCI v5.
Interventions
Sponsors
Institut Bergonie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metastasis progression-free survival (M-PFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014). | — |
Secondary
| Measure | Time frame |
|---|---|
| Loco-regional relapse-free survival (LR-RFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or loco-regional progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2015). Progression-free survival is defined as the time interval between the randomization date and the date of death (whatever the cause) or progression (as per RECIST v1.1), whichever occurs first., Overall survival is defined as the time interval between the randomization date and the date of death (whatever the cause)., Best overall response is defined as the best response recorded from randomization until the end of neoadjuvant chemotherapy taking into account any requirement for confirmation as per RECIST v1.1 criteria, Histological response is defined based on tumour sample as the average proportion of recognizable cells on the tumour sample [Huvos et al, Arch Pathol Lab Med 1977]. Good histological response is defined as <10% vi | — |
Countries
France
Outcome results
None listed