Table 2 CINSARC prospective clinical trials.
From: Predictive and prognostic transcriptomic biomarkers in soft tissue sarcomas
Trial number | Phase | Title | Allocation | Intervention model | Primary outcomes | Secondary outcomes |
|---|---|---|---|---|---|---|
NCT03805022 | III | Benefit of intensified peri-operative chemotherapy within High-risk CINSARC patients with resectable soft-tissue sarcomas (CIRSARC) | Randomised | Parallel assignment | - Metastasis progression-free survival [3 years] | - Loco-regional relapse-free survival [3 years] - Progression-free survival [3 years] - Overall survival [3 years] - Best overall response as per RECIST v1.1 [6 months] - Histological response [6 months] - Adverse events/Toxicity as per NCI-CTCAE v5.0 [6 months] |
NCT02789384 | N/A | Prognostic value of the CINSARC signature and correlation with chemotherapy efficacy in soft-tissue sarcomas. A Biomarker Study. (NEOSarcomics) | N/A | Observational- Single Group Assignment | - Best overall response as per RECIST v1.1 [6 months] | - Histological response [6 months] - Metastasis-free survival [3 years] - Overall survival [3 years] - Adverse events/Toxicity as per NCI-CTCAE v4.0 |
NCT04307277 | III | Interest of peri-operative chemotherapy in patients with CINSARC high-risk localised Grade 1 or 2 soft tissue sarcoma | Randomised | Parallel assignment | - Metastasis-free survival [5 years] | - Disease-free survival [5 years] - Toxicity as per NCI-CTCAE v5.0 - Overall survival [5 years] |
