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

Authors

  • Camilla Skinnerup Byskov Department of Oncology, Aarhus University Hospital, Denmark https://orcid.org/0000-0001-7196-0234
  • Hanna R. Mortensen Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
  • Marie-Claude Biston Centre Léon Bérard, Lyon, France
  • Sara Broggi San Raffaele Hospital, Milan, Italy
  • Rebecca Bütof Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany; OncoRay – National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Helmholtz-Zentrum Dresden-Rossendorf, Dresden, Germany
  • Richard Canters Department of Radiation Oncology (Maastro), GROW School for Oncology and Reproduction, Maastricht University Medical Centre+, The Netherlands
  • Gilles Crehange Curie Institute, Paris, France
  • Gilles Defraene KU Leuven – University of Leuven - Department of Oncology – Laboratory of Experimental Radiotherapy, Belgium
  • Jerome Doyen Centre Antoine Lacassagne, Nice, France
  • Mai L. Ehmsen Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
  • Silvia Fabiano University Hospital Zurich, Zurich, Switzerland
  • Francesco Fracchiola Department of medical physics, APSS, Trento, Italy
  • Farid Goudjil Curie Institute, Paris, France
  • Karin Haustermans KU Leuven – University of Leuven - Department of Oncology – Laboratory of Experimental Radiotherapy, Belgium; University Hospitals Leuven, Department of Radiation Oncology, Belgium
  • Sarah E. Jensen Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
  • Maria F. Jensen Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
  • Marie Lecornu Centre François Baclesse, Caen, France
  • Sebastian Makocki Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany; OncoRay – National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Helmholtz-Zentrum Dresden-Rossendorf, Dresden, Germany
  • Aurélia L. Mana Centre Antoine Lacassagne, Nice, France
  • Andrea Martignano Department of medical physics, APSS, Trento, Italy
  • Arturs Meijers Paul Scherrer Institute, Villigen, Switzerland
  • Alfredo Mirandola National Centre of Oncology Adrotherapy, Pavia, Italy
  • Diana A. Mitrea Centre Antoine Lacassagne, Nice, France
  • Christina T. Muijs Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, The Netherlands
  • Ditte S. Møller Department of Oncology, Aarhus University Hospital, Denmark; Department of Clinical Medicine, Faculty of Health Sciences, Aarhus University, Denmark
  • Marianne Nordsmark Department of Oncology, Aarhus University Hospital, Denmark
  • Ester Orlandi Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences, University of Pavia, Pavia, Italy; Clinical Department, National Center for Oncological Hadrontherapy (Fondazione CNAO), Pavia, Italy
  • Panagiotis Balermpas 1University Hospital Zurich, Zurich, Switzerland
  • Pieter Populaire KU Leuven – University of Leuven - Department of Oncology – Laboratory of Experimental Radiotherapy, Belgium; University Hospitals Leuven, Department of Radiation Oncology, Belgium
  • Daniele Scartoni Department of Proton Therapy, APSS, Trento
  • Jessica Serrand Centre Léon Bérard, Lyon, France
  • Muhammad Shamshad EBG MedAustron GmbH, Austria
  • Najla Slim San Raffaele Hospital, Milan, Italy
  • Valentina Vanoni Department of Radiation Oncology, APSS, Trento, Italy
  • Anthony Vela Centre François Baclesse, Caen, France
  • Marie Vidal Centre Antoine Lacassagne, Nice, France
  • Gloria Vilches-Freixas Department of Radiation Oncology (Maastro), GROW School for Oncology and Reproduction, Maastricht University Medical Centre+, The Netherlands
  • Damien Weber Paul Scherrer Institute, Villigen, Switzerland
  • Lone Hoffmann Department of Oncology, Aarhus University Hospital, Denmark; Department of Clinical Medicine, Faculty of Health Sciences, Aarhus University, Denmark

DOI:

https://doi.org/10.2340/1651-226X.2025.42774

Keywords:

Radiotherapy quality assurance, clinical trials, 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.

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2025-03-13

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Skinnerup Byskov, C., Mortensen, H. R., Biston, M.-C., Broggi, S., Bütof, R., Canters, R., … 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

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Vol. 64 (2025): Acta Oncologica

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Copyright (c) 2025 Camilla Skinnerup 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, Andrea 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, Muhammad Shamshad, Najla Slim, Valentina Vanoni, Anthony Vela, Marie Vidal, Gloria Vilches-Freixas, Damien Weber, Lone Hoffmann

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