Soft Tissue Sarcoma
Conditions
Brief summary
The primary endpoint is Metastasis-free survival (MFS). MFS is defined by the delay between randomization and the appearance of metastatic disease or death from any cause.
Detailed description
Disease-free survival (DFS) is defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause. Patients still alive at the time of analysis (including lost to follow-up) without appearance of relapse will be censored at the last disease assessment date., Overall survival (OS) is defined by the delay between randomization and death from any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date., Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).
Interventions
DRUGsolution injectable
DRUGHOLOXAN 2000 mg
Sponsors
Oncopole Claudius Regaud
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Metastasis-free survival (MFS). MFS is defined by the delay between randomization and the appearance of metastatic disease or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) is defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause. Patients still alive at the time of analysis (including lost to follow-up) without appearance of relapse will be censored at the last disease assessment date., Overall survival (OS) is defined by the delay between randomization and death from any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date., Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0). | — |
Countries
France
Outcome results
None listed