Patients with locally advanced or metastatic low grade endometrial stroma sarcoma
Conditions
Brief summary
Progression-Free Survival (PFS), defined as the time from date of randomization to date of the first documented radiological progression (RECIST 1.1) or death due to any cause.
Detailed description
Between arms: ✓ the overall survival (OS)✓ the safety, ✓ the Quality of Life (QoL), ✓ the time to first subsequent chemotherapy;, The progression-free survival (PFS) after AI reintroduction in the experimental arm, The objective response rate (ORR) after reintroduction of AI in the experimental arm, The duration of response to AI after reintroduction in the experimental arm.
Interventions
Sponsors
Centre Leon Berard
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS), defined as the time from date of randomization to date of the first documented radiological progression (RECIST 1.1) or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Between arms: ✓ the overall survival (OS)✓ the safety, ✓ the Quality of Life (QoL), ✓ the time to first subsequent chemotherapy;, The progression-free survival (PFS) after AI reintroduction in the experimental arm, The objective response rate (ORR) after reintroduction of AI in the experimental arm, The duration of response to AI after reintroduction in the experimental arm. | — |
Countries
France
Outcome results
None listed