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A PRAGMATIC CLINICAL STUDY OF NEOADJUVANT CHEMOTHERAPY FOLLOWED BY SURGERY VERSUS SURGERY ALONE FOR PATIENTS WITH HIGH RISK RETROPERITONEAL SARCOMA

Project description

Rethinking treatment for rare sarcomas

Retroperitoneal sarcomas may be rare, but they are aggressive cancers with few treatment options. Surgery remains the main approach. With this in mind, the EU-funded STREXIT2 project aims to explore whether conducting chemotherapy before surgery can improve outcomes for high-risk patients. Specifically, it will compare outcomes, strengthen subgroup analyses, and assess the cost-effectiveness of different treatment strategies. The research brings together oncologists, surgeons, health economists, and patient representatives to define an evidence-based standard of care. If successful, the project could help health systems deliver more sustainable care for patients facing these challenging cancers.

Objective

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. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.

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Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-MISS-2022-CANCER-01

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Coordinator

ORGANISATION EUROPEENNE POUR LA RECHERCHE ET LE TRAITEMENT DU CANCER AISBL
Net EU contribution
€ 4 113 125,00
Address
Avenue E. Mounier 83
1200 Bruxelles / Brussel
Belgium
Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Links
Total cost
€ 4 113 125,00

Participants (4)