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

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.

Fields of science (EuroSciVoc)

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Keywords

Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)

Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

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

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Coordinator

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 4 113 125,00
Address
Avenue E. Mounier 83
1200 Bruxelles / Brussel
Belgium

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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
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 4 113 125,00

Participants (4)

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