Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer

Camilla S. Byskov; Hanna R. Mortensen; Marie Claude Biston; Sara Broggi; Rebecca Bütof; Richard Canters; Gilles Crehange; Gilles Defraene; Jerome Doyen; Mai L. Ehmsen; Silvia Fabiano; Francesco Fracchiola; Farid Goudjil; Karin Haustermans; Sarah E. Jensen; Maria F. Jensen; Marie Lecornu; Sebastian Makocki; Aurélia L. Mana; An Drea Martignano; Arturs Meijers; Alfredo Mirandola; Diana A. Mitrea; Christina T. Muijs; Ditte S. Møller; Marianne Nordsmark; Ester Orlandi; Panagiotis Balermpas; Pieter Populaire; Daniele Scartoni; Jessica Serrand; Muham Mad Shamshad; Najla Slim; Valentina Vanoni; Anthony Vela; Marie Vidal; Gloria Vilches-Freixas; Damien Weber; Lone Hoffmann

doi:10.2340/1651-226X.2025.42774

Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer

Camilla S. Byskov^*, Hanna R. Mortensen, Marie Claude Biston, Sara Broggi, Rebecca Bütof, Richard Canters, Gilles Crehange, Gilles Defraene, Jerome Doyen, Mai L. Ehmsen, Silvia Fabiano, Francesco Fracchiola, Farid Goudjil, Karin Haustermans, Sarah E. Jensen, Maria F. Jensen, Marie Lecornu, Sebastian Makocki, Aurélia L. Mana, An Drea MartignanoArturs Meijers, Alfredo Mirandola, Diana A. Mitrea, Christina T. Muijs, Ditte S. Møller, Marianne Nordsmark, Ester Orlandi, Panagiotis Balermpas, Pieter Populaire, Daniele Scartoni, Jessica Serrand, Muham Mad Shamshad, Najla Slim, Valentina Vanoni, Anthony Vela, Marie Vidal, Gloria Vilches-Freixas, Damien Weber, Lone Hoffmann

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

Abstract

Purpose: To present results from the trial radiotherapy quality assurance (RTQA) programme of the centres involved in the randomised phase-III PROton versus photon Therapy for esophageal Cancer – a Trimodality strategy (PROTECT)-trial, investigating the clinical effect of proton therapy (PT) vs. photon therapy (XT) for patients with oesophageal cancer. Materials and methods: The pre-trial RTQA programme consists of benchmark target and organ at risk (OAR) delineations as well as treatment planning cases, a facility questionnaire and beam output audits. Continuous on-trial RTQA with individual case review (ICR) of the first two patients and every fifth patient at each participating site is performed. Patient-specific QA is mandatory for all patients. On-site visits are scheduled after the inclusion of the first two patients at two associated PT and XT sites. Workshops are arranged annually for all PROTECT participants. Results: Fifteen PT/XT sites are enrolled in the trial RTQA programme. Of these, eight PT/XT sites have completed the entire pre-trial RTQA programme. Three sites are actively including patients in the trial. On-trial ICR was performed for 22 patients. For the delineation of targets and OARs, six major and 11 minor variations were reported, and for six patients, there were no remarks. One major and four minor variations were reported for the treatment plans. Three site visits and two annual workshops were completed. Interpretation: A comprehensive RTQA programme was implemented for the PROTECT phase III trial. All centres adhered to guidelines for pre-trial QA. For on-trial QA, major variations were primarily seen for target delineations (< 30%), and no treatment plans required re-optimisation.

Original language	English
Journal	Acta Oncologica
Volume	64
Pages (from-to)	406-414
Number of pages	9
ISSN	0284-186X
DOIs	https://doi.org/10.2340/1651-226X.2025.42774
Publication status	Published - 2025

Keywords

clinical trial
oesophageal cancer
Radiotherapy quality assurance

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10.2340/1651-226X.2025.42774

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Byskov, C. S., Mortensen, H. R., Biston, M. C., Broggi, S., Bütof, R., Canters, R., Crehange, G., Defraene, G., Doyen, J., Ehmsen, M. L., Fabiano, S., Fracchiola, F., Goudjil, F., Haustermans, K., Jensen, S. E., Jensen, M. F., Lecornu, M., Makocki, S., Mana, A. L., ... Hoffmann, L. (2025). Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer. Acta Oncologica, 64, 406-414. https://doi.org/10.2340/1651-226X.2025.42774

@article{96a83e136fd447649e3f977596426fef,

title = "Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer",

abstract = "Purpose: To present results from the trial radiotherapy quality assurance (RTQA) programme of the centres involved in the randomised phase-III PROton versus photon Therapy for esophageal Cancer – a Trimodality strategy (PROTECT)-trial, investigating the clinical effect of proton therapy (PT) vs. photon therapy (XT) for patients with oesophageal cancer. Materials and methods: The pre-trial RTQA programme consists of benchmark target and organ at risk (OAR) delineations as well as treatment planning cases, a facility questionnaire and beam output audits. Continuous on-trial RTQA with individual case review (ICR) of the first two patients and every fifth patient at each participating site is performed. Patient-specific QA is mandatory for all patients. On-site visits are scheduled after the inclusion of the first two patients at two associated PT and XT sites. Workshops are arranged annually for all PROTECT participants. Results: Fifteen PT/XT sites are enrolled in the trial RTQA programme. Of these, eight PT/XT sites have completed the entire pre-trial RTQA programme. Three sites are actively including patients in the trial. On-trial ICR was performed for 22 patients. For the delineation of targets and OARs, six major and 11 minor variations were reported, and for six patients, there were no remarks. One major and four minor variations were reported for the treatment plans. Three site visits and two annual workshops were completed. Interpretation: A comprehensive RTQA programme was implemented for the PROTECT phase III trial. All centres adhered to guidelines for pre-trial QA. For on-trial QA, major variations were primarily seen for target delineations (< 30%), and no treatment plans required re-optimisation.",

keywords = "clinical trial, oesophageal cancer, Radiotherapy quality assurance",

author = "Byskov, {Camilla S.} and Mortensen, {Hanna R.} and Biston, {Marie Claude} and Sara Broggi and Rebecca B{\"u}tof and Richard Canters and Gilles Crehange and Gilles Defraene and Jerome Doyen and Ehmsen, {Mai L.} and Silvia Fabiano and Francesco Fracchiola and Farid Goudjil and Karin Haustermans and Jensen, {Sarah E.} and Jensen, {Maria F.} and Marie Lecornu and Sebastian Makocki and Mana, {Aur{\'e}lia L.} and Martignano, {An Drea} and Arturs Meijers and Alfredo Mirandola and Mitrea, {Diana A.} and Muijs, {Christina T.} and M{\o}ller, {Ditte S.} and Marianne Nordsmark and Ester Orlandi and Panagiotis Balermpas and Pieter Populaire and Daniele Scartoni and Jessica Serrand and Shamshad, {Muham Mad} and Najla Slim and Valentina Vanoni and Anthony Vela and Marie Vidal and Gloria Vilches-Freixas and Damien Weber and Lone Hoffmann",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s).",

year = "2025",

doi = "10.2340/1651-226X.2025.42774",

language = "English",

volume = "64",

pages = "406--414",

journal = "Acta Oncologica",

issn = "0284-186X",

publisher = "Medical Journals Sweden AB",

}

Byskov, CS, Mortensen, HR, Biston, MC, Broggi, S, Bütof, R, Canters, R, Crehange, G, Defraene, G, Doyen, J, Ehmsen, ML, Fabiano, S, Fracchiola, F, Goudjil, F, Haustermans, K, Jensen, SE, Jensen, MF, Lecornu, M, Makocki, S, Mana, AL, Martignano, AD, Meijers, A, Mirandola, A, Mitrea, DA, Muijs, CT, Møller, DS , Nordsmark, M, Orlandi, E, Balermpas, P, Populaire, P, Scartoni, D, Serrand, J, Shamshad, MM, Slim, N, Vanoni, V, Vela, A, Vidal, M, Vilches-Freixas, G, Weber, D & Hoffmann, L 2025, 'Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer', Acta Oncologica, vol. 64, pp. 406-414. https://doi.org/10.2340/1651-226X.2025.42774

Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer. / Byskov, Camilla S.; Mortensen, Hanna R.; Biston, Marie Claude et al.
In: Acta Oncologica, Vol. 64, 2025, p. 406-414.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer

AU - Byskov, Camilla S.

AU - Mortensen, Hanna R.

AU - Biston, Marie Claude

AU - Broggi, Sara

AU - Bütof, Rebecca

AU - Canters, Richard

AU - Crehange, Gilles

AU - Defraene, Gilles

AU - Doyen, Jerome

AU - Ehmsen, Mai L.

AU - Fabiano, Silvia

AU - Fracchiola, Francesco

AU - Goudjil, Farid

AU - Haustermans, Karin

AU - Jensen, Sarah E.

AU - Jensen, Maria F.

AU - Lecornu, Marie

AU - Makocki, Sebastian

AU - Mana, Aurélia L.

AU - Martignano, An Drea

AU - Meijers, Arturs

AU - Mirandola, Alfredo

AU - Mitrea, Diana A.

AU - Muijs, Christina T.

AU - Møller, Ditte S.

AU - Nordsmark, Marianne

AU - Orlandi, Ester

AU - Balermpas, Panagiotis

AU - Populaire, Pieter

AU - Scartoni, Daniele

AU - Serrand, Jessica

AU - Shamshad, Muham Mad

AU - Slim, Najla

AU - Vanoni, Valentina

AU - Vela, Anthony

AU - Vidal, Marie

AU - Vilches-Freixas, Gloria

AU - Weber, Damien

AU - Hoffmann, Lone

PY - 2025

Y1 - 2025

N2 - Purpose: To present results from the trial radiotherapy quality assurance (RTQA) programme of the centres involved in the randomised phase-III PROton versus photon Therapy for esophageal Cancer – a Trimodality strategy (PROTECT)-trial, investigating the clinical effect of proton therapy (PT) vs. photon therapy (XT) for patients with oesophageal cancer. Materials and methods: The pre-trial RTQA programme consists of benchmark target and organ at risk (OAR) delineations as well as treatment planning cases, a facility questionnaire and beam output audits. Continuous on-trial RTQA with individual case review (ICR) of the first two patients and every fifth patient at each participating site is performed. Patient-specific QA is mandatory for all patients. On-site visits are scheduled after the inclusion of the first two patients at two associated PT and XT sites. Workshops are arranged annually for all PROTECT participants. Results: Fifteen PT/XT sites are enrolled in the trial RTQA programme. Of these, eight PT/XT sites have completed the entire pre-trial RTQA programme. Three sites are actively including patients in the trial. On-trial ICR was performed for 22 patients. For the delineation of targets and OARs, six major and 11 minor variations were reported, and for six patients, there were no remarks. One major and four minor variations were reported for the treatment plans. Three site visits and two annual workshops were completed. Interpretation: A comprehensive RTQA programme was implemented for the PROTECT phase III trial. All centres adhered to guidelines for pre-trial QA. For on-trial QA, major variations were primarily seen for target delineations (< 30%), and no treatment plans required re-optimisation.

AB - Purpose: To present results from the trial radiotherapy quality assurance (RTQA) programme of the centres involved in the randomised phase-III PROton versus photon Therapy for esophageal Cancer – a Trimodality strategy (PROTECT)-trial, investigating the clinical effect of proton therapy (PT) vs. photon therapy (XT) for patients with oesophageal cancer. Materials and methods: The pre-trial RTQA programme consists of benchmark target and organ at risk (OAR) delineations as well as treatment planning cases, a facility questionnaire and beam output audits. Continuous on-trial RTQA with individual case review (ICR) of the first two patients and every fifth patient at each participating site is performed. Patient-specific QA is mandatory for all patients. On-site visits are scheduled after the inclusion of the first two patients at two associated PT and XT sites. Workshops are arranged annually for all PROTECT participants. Results: Fifteen PT/XT sites are enrolled in the trial RTQA programme. Of these, eight PT/XT sites have completed the entire pre-trial RTQA programme. Three sites are actively including patients in the trial. On-trial ICR was performed for 22 patients. For the delineation of targets and OARs, six major and 11 minor variations were reported, and for six patients, there were no remarks. One major and four minor variations were reported for the treatment plans. Three site visits and two annual workshops were completed. Interpretation: A comprehensive RTQA programme was implemented for the PROTECT phase III trial. All centres adhered to guidelines for pre-trial QA. For on-trial QA, major variations were primarily seen for target delineations (< 30%), and no treatment plans required re-optimisation.

KW - clinical trial

KW - oesophageal cancer

KW - Radiotherapy quality assurance

UR - http://www.scopus.com/inward/record.url?scp=105000227400&partnerID=8YFLogxK

U2 - 10.2340/1651-226X.2025.42774

DO - 10.2340/1651-226X.2025.42774

M3 - Journal article

C2 - 40079654

AN - SCOPUS:105000227400

SN - 0284-186X

VL - 64

SP - 406

EP - 414

JO - Acta Oncologica

JF - Acta Oncologica

ER -

Radiotherapy quality assurance in the PROTECT trial – a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer

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Keywords

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