Clinical research in this phase will be oriented especially towards participation in multicentre studies, both academic and sponsored, having the following principal interests:
- – Identification of dedicated clinical research data managers and nurses, with training and interaction with the clinical research team
– Optimisation of treatments integrated with surgery and radiotherapy differentiated by isotype or disease site in patients with high-risk localised disease
– Development of systemic treatments with new drugs or for evaluating the activity/efficacy of known drugs not studied for sarcoma
– Evaluation of possible new areas of research (identification of targets, proposals for collaborative studies), new local therapy approaches in collaboration with interventional radiology and participation in multicentre studies for evaluating the genetics/families of patients with sarcoma
Specifically:
– Preoperative treatment in high-risk localised disease, comparing a standard chemotherapy with a chemotherapy targeted by isotype, as part of a study coordinated by Italian, Spanish and French Sarcoma Groups (already active).
– Evaluation, within studies under development, of the role of treatments with monoclonal antibodies (e.g. Ab-PDGFRA Olaratumab, phase II submitted to ASCO with doubling of OS at 23 months in metastatic sarcomas, rapid FDA approval scheduled), chemotherapy in precise subgroups (e.g. eribulin in liposarcomas, alkylating oral medicines in EORTC studies), target drugs (e.g. regorafenib in STS, NTRK inhibitors, following evaluation via pilot studies of NTRK mutations in various subtypes of soft tissue sarcoma).
– Evaluation of precautionary treatment of high-risk patients with GIST with schemes implemented over the standard (masitinib)
– National data collection via the Italian Sarcoma Group as part of radiation-induced angiosarcomas for possible creation of a study of a precautionary chemotherapy treatment in breast angiosarcoma
– Collaborative evaluation with interventional radiology for the integration of chemoembolisation/thermoablation with systemic therapy in the treatment of patients with GIST and soft tissue sarcoma (potential development of a phase 2 protocol to validate the choice of RAI in place of surgery in metastatic patients)