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Proton versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Objective

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.

Call for proposal

H2020-JTI-IMI2-2020-20-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

AARHUS UNIVERSITET
Address
Nordre Ringgade 1
8000 Aarhus C
Denmark
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 801 631,25

Participants (18)

AARHUS UNIVERSITETSHOSPITAL
Denmark
EU contribution
€ 98 873,75
Address
Palle Juul-jensens Boulevard 99
8200 Aarhus
Activity type
Research Organisations
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 137 825
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 91 430
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
UNIVERSITY OF LEEDS
United Kingdom
EU contribution
€ 46 983,75
Address
Woodhouse Lane
LS2 9JT Leeds
Activity type
Higher or Secondary Education Establishments
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 146 998,75
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
HOLLAND PARTICLE THERAPY CENTRE BV
Netherlands
EU contribution
€ 78 200
Address
Huismansingel 4
2629JH Delft
Activity type
Research Organisations
TECHNISCHE UNIVERSITAET DRESDEN
Germany
EU contribution
€ 28 728,75
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
PAUL SCHERRER INSTITUT
Switzerland
EU contribution
€ 28 728,75
Address
Forschungstrasse 111
5232 Villigen Psi
Activity type
Research Organisations
STICHTING MAASTRICHT RADIATION ONCOLOGY MAASTRO CLINIC
Netherlands
EU contribution
€ 5 075
Address
Dr. Tanslaan 12
6229 ET Maastricht
Activity type
Research Organisations
FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA
Italy
EU contribution
€ 5 075
Address
Strada Campeggi 53
27100 Pavia Pv
Activity type
Research Organisations
AZIENDA PROVINCIALE PER I SERVIZI SANITARI
Italy
EU contribution
€ 5 075
Address
Via Degasperi 79
38100 Trento
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
CENTRE ANTOINE LACASSAGNE
France
EU contribution
€ 5 075
Address
Avenue Valombrose 33
06054 Nice Cedex
Activity type
Research Organisations
INSTITUT CURIE
France
EU contribution
€ 5 075
Address
Rue D'ulm 26
75231 Paris
Activity type
Research Organisations
CENTRE DE LUTTE CONTRE LE CANCER LEON BERARD
France
EU contribution
€ 5 075
Address
Rue Laennec 28
69373 Lyon
Activity type
Research Organisations
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH & CO. KG
Germany
EU contribution
€ 0
Address
Mottmannstrasse 2
53842 Troisdorf
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ION BEAM APPLICATIONS SA
Belgium
EU contribution
€ 0
Address
Chemin Du Cyclotron 3
1348 Ottignies Louvain La Neuve
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE CHRISTIE NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 5 075
Address
Wilmslow Road 1
M20 4BX Manchester
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 5 075
Address
Euston Road 250
NW1 2PG London
Activity type
Research Organisations