STREXIT 2 Project

Retroperitoneal sarcomas are rare diseases refractory to treatment with a dismal prognosis. Surgery is the only standard approach to primary disease. We are proposing an innovative pragmatic approach supplementing a standard phase III clinical trial with an observational cohort. STREXIT2 is proposed to amend the ongoing phase III EORTC clinical trial STRASS2 investigating the added value of neoadjuvant chemotherapy before surgery for high-risk retroperitoneal sarcoma and to add an observational arm STREXIT2 that will capture real-world data from patients not participating to STRASS2. We will compare the clinical outcomes between STRASS2 and STREXIT2 and explore the possible combination of STRASS2 and matched STREXIT2 patients to strengthen the results of the randomized clinical trial data and increase the power of subgroup analyses. We will perform health economics analysis assessing the economic value of different treatment scenarios based on STRASS2 and STREXIT2. If successful, the outcomes of the project will define a new evidence-based standard of care for high-risk retroperitoneal sarcomas. The proposed research could lead to improved patient survival and quality of life but also improving health system sustainability. We are a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists and patient representatives. The study design was successfully discussed with patients. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’. © The STREXIT2 Consortium 2023-2028. This project has received funding from the European Union’s HORIZON-MISS-CANCER-2022-01 under grant agreement Nº (101103843). Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.