Periodic Reporting for period 1 - STREXIT2 (A PRAGMATIC CLINICAL STUDY OF NEOADJUVANT CHEMOTHERAPY FOLLOWED BY SURGERY VERSUS SURGERY ALONE FOR PATIENTS WITH HIGH RISK RETROPERITONEAL SARCOMA)
Période du rapport: 2023-06-01 au 2024-05-31
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 development of the STREXIT2 project is progressing according to plan. The first action was to amend the ongoing phase III EORTC clinical trial STRASS2 protocol to add the observational arm that will collect the clinical data needed for STREXIT2. The amendment to the trial protocol was submitted under the Clinical Trial Regulation and we received the regulatory approval in February 2024. The first clinical site was authorised for patient recruitment end of May 2024. The first patient was recruited in the STREXIT2 arm on 4th June 2024.
On the health economics side, as it was planned, the activities have been initiated at project start. The explorative work was carried out, input for the study protocol was provided and input from the clinical experts was collected. These resulted in the conceptual value framework, which was submitted as the first deliverable from this work.
Finally, regarding communication and dissemination, all milestones and deliverables were completed in time. Project website, social media platforms and newsletters were launched. The deliverable of Plan for dissemination and exploitation was prepared. The first webinar was released. Active communication is carried out according to progress of the clinical trial.
In conclusion, the project is progressing well and according to the planed timelines.
On the health economics side, as it was planned, the activities have been initiated at project start. The explorative work was carried out, input for the study protocol was provided and input from the clinical experts was collected. These resulted in the conceptual value framework, which was submitted as the first deliverable from this work.
Finally, regarding communication and dissemination, all milestones and deliverables were completed in time. Project website, social media platforms and newsletters were launched. The deliverable of Plan for dissemination and exploitation was prepared. The first webinar was released. Active communication is carried out according to progress of the clinical trial.
In conclusion, the project is progressing well and according to the planed timelines.
It is too early. The project clinical trial has not yet delivered any result.