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Proton versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Descrizione del progetto

Sperimentazione clinica sulla protonterapia per il cancro all’esofago

L’obiettivo del progetto PROTECT-trial, finanziato dall’UE, è quello di confrontare i risultati clinici della protonterapia e della radioterapia convenzionale durante uno studio randomizzato e di applicare i risultati per far progredire il campo del trattamento protonterapico basato sulle evidenze. Uno studio randomizzato di durata triennale coinvolgerà 396 pazienti affetti da cancro esofageo, 13 unità di reclutamento e 34 istituzioni di nove paesi europei. Tutti i centri di protonterapia coinvolti dispongono di attrezzature all’avanguardia con scansione a fascio di matita e controllo volumetrico dell’immagine. Gli endpoint forniranno dati sul controllo, sulla sopravvivenza e sugli effetti collaterali del tumore, nonché sugli aspetti economici dell’assistenza sanitaria. I risultati dello studio avranno importanti implicazioni in relazione alla gestione della trimodalità non solo del cancro all’esofago, ma anche di altri tipi di tumore.

Obiettivo

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.

Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

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

Mostra sulla mappa

Regione
Danmark Midtjylland Østjylland
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 1 275 321,25

Partecipanti (18)