Periodic Reporting for period 2 - STREXIT2 (A PRAGMATIC CLINICAL STUDY OF NEOADJUVANT CHEMOTHERAPY FOLLOWED BY SURGERY VERSUS SURGERY ALONE FOR PATIENTS WITH HIGH RISK RETROPERITONEAL SARCOMA)
Periodo di rendicontazione: 2024-06-01 al 2025-11-30
Retroperitoneal sarcomas are rare diseases refractory to treatment with 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. It 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. If conclusive, the proposed research will help to understand the clinical added value and costs-effectiveness of neoadjuvant chemotherapy before surgery for high-risk retroperitoneal sarcoma. 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. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists and patient representatives. The study design was successfully discussed with patients
The first patient was recruited on 4th June 2024 in the STREXIT2 arm of the clinical trial STRASS2. We are experiencing a delay in recruitment since 165 patients were recruited in STREXIT2 as of end of November 2025 instead of the expected double number of patients. This is still a remarkable achievement given the rarity of the disease. As a matter of facts, we have included in STREXIT2 as many patients as in STRASS2, already doubling the number of patients available for analysis. We stimulated the participating clinical sites to recruit patients faster. In addition, the study protocol was amended to allow the enrolment of deceased patients which should help as well, since for some time this was not possible and many of the retrospective patients had in fact died. On the health economics side, as it was planned, the activities have been ongoing since project start. Finally, regarding communication and dissemination, we published one scientific article, project newsletters and we posted on social media. The project website is updated.
It is too early. The project clinical trial has not yet delivered any result.