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Proton versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Description du projet

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Un essai clinique de protonthérapie pour le cancer de l’œsophage

L’objectif du projet PROTECT-trial, financé par l’UE, consiste à comparer les résultats cliniques de la protonthérapie et de la radiothérapie conventionnelle dans le cadre d’une étude randomisée et à appliquer ces résultats pour faire avancer le domaine de la protonthérapie fondée sur des données probantes. Un essai randomisé sera mené auprès de 396 patients atteints de cancer de l’œsophage, impliquant 13 services de recrutement et 34 institutions de 9 pays européens, et il se déroulera sur 3 ans. Tous les centres de protonthérapie participants disposent d’un équipement de pointe: balayage à faisceau filiforme et orientation par images volumétriques. Les critères fourniront des données sur le contrôle de la tumeur, la survie, les effets secondaires et l’économie sanitaire. Les résultats de l’essai auront d’importantes répercussions sur la prise en charge trimodale pour le cancer de l’œsophage et pour d’autres types de cancer.

Objectif

The aim of PROTECT-trial is to compare the clinical outcome of proton therapy (PT) and conventional radiotherapy in a randomized study and to use the data and experience to advance the field of evidence-based medicine in PT.
A randomized trial with 396 patients is planned involving 13 recruiting units and 34 institutions from nine European countries in an accrual period of three years. All involved PT centers have state-of-the-art equipment, including pencil beam scanning and volumetric image guidance. The endpoints will include side effects, tumor control, survival, and health economics aspects. PROTECT-trial will use experience from the trial, combined with parallel experience from other trial methodologies, to create a consensus model for the selection of patients both for referral for standard PT and for enrollment in clinical trials. This model will be based on esophageal cancer but will have wider implications, which can be used in all European countries and for other cancer types.
PROTECT-trial will result in new evidence for the role of PT in cancer management. PROTECT-trial will advance the quality of care for trimodality management of esophageal cancer. The large trial will provide statistically robust results at a high level of clinical evidence and will allow a successful trial to trigger an international change in clinical practice. If the PROTECT trial is positive, PT will become a standard option for a large patient population. The patients will recover faster from their treatment and live a better life with fewer side effects and more years at work. The results will have high relevance for other cancer types where protons also lower the dose to sensitive normal tissues. Notably, PROTECT-trial will actively engage with patients, providers, payers, and other stakeholders to design and report the study. Finally, PROTECT-trial will contribute with Health Technology Assessment and provide economic evidence of high relevance to reimbursement decisions in Europe.

Champ scientifique

Mots‑clés

Programme(s)

Thème(s)

Appel à propositions

H2020-JTI-IMI2-2020-20-two-stage

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Régime de financement

RIA - Research and Innovation action

Coordinateur

AARHUS UNIVERSITET
Contribution nette de l'UE
€ 801 631,25
Adresse
NORDRE RINGGADE 1
8000 Aarhus C
Danemark

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Région
Danmark Midtjylland Østjylland
Type d’activité
Higher or Secondary Education Establishments
Liens
Coût total
€ 1 275 321,25

Participants (18)

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Dernière mise à jour: 20 Juin 2024

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Permalink: https://cordis.europa.eu/project/id/101008134/fr

European Union, 2024