The PROTECT-trial consortium has 19 partners across Europe.
Main tasks attributed in the project.
Active member of the General Assembly and Executive Committee to provide guidance and support for the execution of the project according to plan as well as financial support to the project. Varian team members contribute to WP1, WP2, WP3, WP6, WP9, WP10 and WP11 with industrial experience and support.
About Varian Medical Systems Particle Therapy GmbH & CO. KG (Varian)
At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 11,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com and follow @VarianMedSys on Twitter.
Main tasks attributed in the project
AU contributes as Coordinator (WP11) in coordinating the administrative, legal, financial, and ethical matters. AU will also lead WP2 and be responsible for trial management, including setting up the CTO. In addition, AU will contribute to the work in WP1, WP3, WP7, WP9 and WP10.
About Aarhus University (AU)
Aarhus University is the second largest university in Denmark. AU has been establishing itself as a university for cutting-edge research and has been moving up the most important university ranking lists. In 2019, the university is ranked at number 108 at the Leiden Ranking, number 145 at the QS World University Ranking, and number 115 of 17,000 universities on the Times Higher Education World University Ranking. AU has participated in 295 FP7 and 335 H2020 projects – 21 and 35, respectively, as coordinator – and has hosted/is currently hosting 54 ERC projects. The Department of Clinical Medicine is Denmark’s largest health science institute conducting research in almost all medical specialties. The Department has a Clinical Trials Unit, with all the necessary infrastructure and expertise for central trial and data management, legal and biostatistical advice, and Good Clinical Practice (GCP). The Research Support Office at AU has expertise in EU project management, including financial reporting, reports to EU, support for monitoring project activities and meetings, communication with the funder, follow-up, and quality control of reports.
Main tasks attributed in the project
Surgery Quality Assurance (WP4 lead). Contributions to WP1, WP4, WP8, WP10, WP11. KULeuven is actively involved in the protocol writing (including radiotherapy delineation guidelines) and the radiation therapy and surgery quality assurance work packages. Besides patient recruitment and treatment, we will also play an active role in the work packages on translational research, innovative trial methodologies and the overall project management, communication and dissemination of project results. Prof. Dr. Karin Haustermans is co-PI of the PROTECT trial.
About Catholic University of Leuven (KULeuven)
KULeuven boasts a rich tradition of education and research that dates back six centuries. The university’s basic research orientation has always been and will remain fundamental research. At the same time, the university remains vigilantly open to contemporary cultural, economic and industrial realities, as well as to the community’s needs and expectations. From a basis of social responsibility and scientific expertise, KULeuven provides high-quality, comprehensive health care, including specialized tertiary care, in its University Hospitals UZ Leuven. In doing so it strives toward optimum accessibility and respect for all patients. KULeuven is currently by far the largest university in Belgium in terms of research funding and expenditure (EUR 522 million in 2019) and is a charter member of LERU. KULeuven conducts fundamental and applied research in all academic disciplines with a clear international orientation. In the Times Higher Education ranking KULeuven is ranked as the 13th European university, while in the Reuters Top 100 of the World’s most innovative institutions, KULeuven is listed as the first European university, for the fourth year in a row. In Horizon 2020, KULeuven currently has been approved for more than 450 projects and is ranked fifth HES institution with regard to number of signed grants (482, worth more than 274 million euro). KULeuven takes up the 11th place of European HES institutions hosting ERC grants (as first legal signatories of the grant agreement, ERC annual report 2018). To date, the over 100 ERC grants involving KULeuven researchers, (including affiliates with VIB and IMEC) confirm that KULeuven is a breeding ground and attractive destination for the world’s best researchers. The success in the FP7 and Horizon 2020 Marie Sklodowska Curie Actions is a manifestation of the three pillars of KULeuven: research, education and service to society. In Horizon 2020, we are involved in 97 Innovative Training Networks, ranking us first institution of higher education with regard to number of MSCA-ITNs. In addition, we are hosting 78 MSCA Individual Fellows. The Department of Radiation Oncology of UZ Leuven disposes of 5 linear accelerators and a bunker for high dose rate brachytherapy. The proton therapy center PARTICLE, which is operational since July 2020, is part of the department and fully integrated within the existing academic hospital. The center encompasses two vaults: one for the treatment of patients and one dedicated vault for research purposes. Importantly, the two vaults have their own accelerator, i.e. a superconducting synchrocyclotron. A Proteus®ONE system capable of pencil beam scanning is installed in the clinical vault with the full scope of imaging modalities (kV-kV, CBCT), including an in-room dual energy CT on-rails. The Laboratory of Experimental Radiotherapy of KULeuven, which is tightly linked to the clinical department, is fully equipped to perform both basic and translational radiobiological-oriented research, including a high precision samll animal irradiator.
Main tasks attributed in the project
Innovative trial methodologies (WP10 lead), Radiation Therapy Quality Assurance (WP3 co-lead). Contributions to WP1, WP8, WP9, WP11. Selection of eligible patients for the trial at multidisciplinary boards, RT and PT, follow-up of trial patients after treatment.
About Academisch Ziekenhuis Groningen (UMGC)
The UMCG is the largest University Medical Center in the Netherlands. The UMCG has 3 major research pillars: mechanisms of diseases, prevention and innovative diagnostics and treatments. Within this project, the department of Radiation Oncology of the UMCG is involved. Building on the UMCG mission, the mission of the department is ‘High precision, Innovation and Healthy Ageing of Cancer Survivors’. Since January 2018 UMCG has been treating patients with proton therapy in the state-of-the-art UMC Groningen Proton Therapy Center (GPTC). In the meantime, UMCG has treated over 600 patients and this number will further increase the next years. The research proposed in this project perfectly aligns with this mission enabling to further explore and utilize the potential benefits of proton therapy.
Main tasks attributed in the project
Health Economics (WP7 co-lead). Contributions to WP10, WP11. Responsible for data collection of cost-effectiveness parameters (i.e. resource use, health related quality of life) and conducting the health technology assessment of proton therapy vs. photon therapy alongside the PROTECT trial.
About Holland Particle Therapy Centre B.V. (HollandPTC)
HollandPTC holds one of the four Dutch national permits for proton therapy clinics, and is an independent clinic and research centre in which Delft University of Technology (TU Delft), LUMC and Erasmus MC collaborate in providing excellent patient care and ground-breaking research for various tumour types eligible for proton therapy. As of September 2018, HollandPTC is treating patients with complex oncologic tumours and has the ambition to be one of the world-wide leading institutes in the field of proton therapy.
Main tasks attributed in the project
Contributions to WP1, WP3, WP8, WP10, WP11. The main tasks include participation in the QA program and the Innovative trial methodologies WP. Selection of eligible patients for the trial at multidisciplinary boards, RT and PT, follow-up of trial patients after treatment.
About Stichting Maastricht Radiation Oncology (Maastro)
Maastro is an independent academic radiation oncology institute that provides radiotherapy treatment (including proton therapy) to cancer patients in the South-East of the Netherlands. Maastro is the only radiotherapy institute in the province of Limburg (~1M people) and serves the province for radiotherapy. The mission of Maastro is to provide cancer treatment with the greatest chance of cure and / or with the least possible physical and mental side effects. For this purpose, Maastro innovates along strategic goals, i.e. more precise radiation, individualized care, combined radiation and medication treatment, multidisciplinary collaboration and fast innovation implementation. Maastro treats 4,000 patients per year, has a revenue of 33 million euros and employs 250 FTE (end of fiscal year 2018). All academic personnel have also an appointment at the university and the university hospital. The proton therapy facility is fully integrated in Maastro and serves the south-eastern part of The Netherlands (~5.5M people). Maastro has a certified Clinical Trial Office with extensive experience in coordination of multidisciplinary consortia. Maastro is a Mevion proton facility.
Main tasks attributed in the project
Contributions to WP1, WP11. Selection of eligible patients for the trial at multidisciplinary boards, PT of randomized patients, follow-up of trial patients after treatment.
About Azienda Provinciale Per I Servizi Sanitari (APSS)
APSS is the public Institution delivering healthcare to the region of Trentino (0.5M inhabitants). Among other things, APSS runs the general hospital in Trento, which includes the Proton therapy Centre, and a number of smaller hospitals in the region. APSS is active in research collaborations with local and national institutions such as Trento University, Fondazione Bruno Kessler (FBK), The Center for Integrative Biology (CIBIO), the Italian Institute for Nuclear Physics (INFN). APSS will participate in the project via the Proton Department, the Radiation Oncology Department, the Oncology Department and the Surgery Department. The proton therapy center is equipped with two 360° gantries treating patients with pencil beam scanning-based proton therapy. One of the two gantries is equipped with an “on rail” computer tomography (CT), for patient alignment and treatment adaptation based on high quality volumetric imaging. The center is active since end of 2014 and has treated more than a 1000 patients so far. In the past two years the department also gained significant experience in treating moving target with protons, for both abdominal lesions (e.g. liver) and thoracic lesions (e.g. thymoma, lymphomas, etc.). The Radiation oncology department has a long lasting experience in treating patients with state of the art techniques, starting with the application of IMRT in the early 00’s and now including Volumetric Arc Therapy and the use of cone beam imaging for daily patient positioning.
Main tasks attributed in the project
Selection of eligible patients for the trial at multidisciplinary boards, PT of randomized patients, follow-up of trial patients after treatment (accrual estimated 20 patients).
About Centre Antoine-Lacassagne (CAL)
Centre Antoine-Lacassagne is a comprehensive anti-cancer center in Nice. The proton center has one gantry room. The first patient was treated with proton therapy in 2016. Surgery will be performed by the CHU teaching hospital, Nice, France.
Main tasks attributed in the project
Contribution to WP1, WP11. Selection of eligible patients for the trial at multidisciplinary boards, PT of randomized patients, follow-up of trial patients after treatment.
About University College Hospital (UCLH)
University College London Hospital provides a comprehensive service to diagnose, treat and support people with cancer. We are a specialist center for many types of cancer and treat patients from both our local area and across the country. UCLH is a specialist centre for the diagnosis and treatment of oesophageal and gastric cancer. This means that patients will have some of their cancer treatment at their local hospital, but may be seen at UCLH for some specialist treatment, for example, surgery or specialist radiotherapy. There are multidisciplinary expert teams to provide cancer care from state-of-the-art facilities, including the award winning University College Hospital Macmillan Cancer Centre. UCLH is at the forefront of developing cancer care. They are one of the 2 NHS proton centres in the UK.
Main Tasks attributed in the project.
Active member of the General Assembly and Executive Committee to provide guidance and support for the execution of the project according to plan as well as financial support to the project. The main specific tasks are in WP9: Maximize impact of trial through professional Community and industry relations and WP11: Project Management, alignment between industry and Public partners In addition, IBA will provide industry input and in-kind contribution to the work in WP1, 2, 3, 6, 7, 8, and 10.
About Ion beam Application SA (IBA)
Ion Beam Applications S.A. is a global medical technology company focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer. With over 100.000 patients treated on IBA’s proton therapy systems since 2001, the company is the worldwide technology leader in the field of proton therapy, considered to be the most advanced form of radiation therapy available today. Fully committed to proton therapy, IBA gathers the largest community of users with 36 centers treating patients worldwide. Over the last 20 years, IBA brought to its users most of the innovative technologies in proton therapy as well as in dosimetry equipment and software. The company continues to invest significantly in research and development focusing among other programs on motion management, ARC therapy and FLASH irradiation with protons. In addition to its proton therapy and radiation dosimetry business, IBA also develops particle accelerators for the medical world and industry. Headquartered in Belgium and employing about 1,500 people worldwide, IBA has installed over 500 particle accelerators across the world.
Main tasks attributed in the project
Protocol and Recruitment (WP1 lead). Radiation therapy Quality Assurance (WP3 lead), Patient Involvement (WP6 co-lead), contribution to WP2, WP4, WP8, WP10, WP11. National coordinator for selection of eligible patients for the trial at multidisciplinary boards, XT and PT, follow-up of trial patients after treatment, at five Danish XT + PT departments. Recruitment, treatment and follow-up for trial patients (PT+XT) at AUH (Department of Oncology and Danish Center for Particle Therapy).
About Aarhus University Hospital (AUH)
Aarhus University Hospital belongs to the elite of university hospitals with the aim to be the best choice for patients and professionals. For 12 years in a row Aarhus University Hospital has been appointed Denmark’s best hospital and was elected the 11th best hospital in the world in 2020 (https://www.newsweek.com/best-hospitals-2020). AUH develops and provides highly specialized treatment, research, and education at an eminent international level. AUH has a major focus on research and innovation, as evidenced by the close interaction with Aarhus University and related biotech and biomedical industry partners. Within recent years, AUH has been successfully involved in more than 26 collaborative EU projects including IMI-projects. AUH hosts the Danish Center for Particle Therapy (DCPT), the national proton center with three gantry rooms and pencil beam beam scanning.
Main tasks attributed in the project
Statistics, including trial design, statistical analysis plan, on-trial reporting, and final data analysis (WP5 lead). Contributions to WP1, WP8, WP10, WP11. Personnel from University of Leeds will lead the biostatistics and data analysis work package. This will involve major contributions to trial design and protocol writing, development of statistical analysis plan, on-trial reporting to the Trial Steering Committee and the Independent Data Monitoring Committee, and final data analysis. Further contributions will be made to translational work around outcome and toxicity prediction.
About University of Leeds (UNIVLEEDS)
The University of Leeds is acclaimed world-wide for the quality of its teaching and research and has been frequently ranked within the top 100 universities worldwide. Leeds is also a leading member of the UK’s prestigious research-intensive Russell Group universities. In 2018/19 it had an annual income in excess of €792m and its annual research income exceeded £151m. Under Horizon 2020 Leeds is currently coordinating 133 H2020 projects and is a partner in a further 127 successful projects (3 of which are IMI2 projects). Leeds’ total research income from Horizon 2020 is currently over €150m. The Leeds Institute of Medical Research (LIMR) at St. James’s is the largest research institute in the School of Medicine and is closely linked to Leeds Cancer Centre, which provides comprehensive clinical cancer services. The Radiotherapy Research Group at St James’s is part of the Cancer Research UK Radiotherapy Centres of Excellence (RadNet) network (£3.5m funding). The Leeds Clinical Trials Research Unit, also in the School of Medicine, is one of the largest trial units in the UK and hosts a £14m world-leading portfolio of innovative and practice changing cancer trials, with radiotherapy as one of thier special areas of interest.
Main tasks attributed
in the project Patient Involvement (WP6 co-lead) and Health Economics (WP7 co-lead). Contributions to WP1, WP4, WP8, WP10, WP11. National coordinator for selection of eligible patients for the trial at multidisciplinary boards, XT and PT, follow-up of trial patients after treatment, at two UK proton centers (London and Manchester) and 10 UK RT departments.
About University College London (UCL)
UCL is London’s leading multidisciplinary university, with more than 13,000 staff and 38,000 students from 150 different countries. UCL has a global reputation for excellence in research and is committed to delivering impact and innovations that enhance the lives of people in the UK, across Europe and around the world. UCL was identified by the UK Research Excellence Framework as the top university in the UK for research strength and UCL is consistently placed in the global top 20 across a wide range of university rankings (currently joint 7th in the QS World University Ranking. UCL’s total competitively awarded research income annually stands at an impressive € 574 million, of which 11% is European funded research & innovation. UCL is one of the leading recipients of European Framework Programme grants, with over 700 projects funded during the Seventh Framework Programme (FP7) and over 520 projects under Horizon 2020 (including 116 ERC grants, 116 MSCA individual fellowships and 217 collaborative RIA, IA and CSA projects UCL hosts CRUK City of London Centre (world class hub for cancer biotherapeutics) which created the CRUK Radiation Research Unit (RRU). The unit has an ambitious research program for radiation oncology and radiation biology. It brings together researchers from various departments in UCL and works closely with University College London Hospitals NHS FT and the Christie’s NHS FT in Manchester. These two hospitals are the designated NHS protons centers.
Main tasks attributed
in the project. Translational research (WP8 lead). Contributions to WP1, WP10, WP11. Patient accrual, Work Package Leader Translational research, Member of the QA Committee. Selection of eligible patients for the trial at multidisciplinary boards, XT and PT, follow-up of trial patients after treatment.
About Technische Universität Dresden (TUD)
The Technische Universität Dresden is one of the leading and most dynamic universities in Germany and was selected by the German government as a ‘University of Excellence’. TUD has about 32,000 students and over 7,800 employees, 560 professors among them. As a full-curriculum university with 17 faculties in five schools, it offers a broad variety of 129-degree programmes and covers a wide research spectrum.
Main tasks attributed in the project
Professional Community and Industry Relations (WP9 lead). Contributions to WP1, WP8, WP10, WP11. Selection of eligible patients for the trial at multidisciplinary boards, PT, follow-up of trial patients after treatment.
About Paul Scherrer Institute (PSI)
PSI performs world-class research in three main subject areas: Matter and Material; Energy and the Environment; and Human Health. PSI is part of the Swiss federal technical university ETH’s domain. In the area of human health, PSI has two structures, a large BIO department and the Center for Proton Therapy that has been treating cancer patients since 1986, equipped with two gantries and active scanning beam.
Main tasks attributed in the project
Contributions to WP1, WP11. Selection of eligible patients for the trial at multidisciplinary boards, PT of randomized patients, follow-up of trial patients after treatment, collaborating in dissemination activities and scientific papers.
About Centro Nazionale di Adroterapia Oncologica (CNAO)
CNAO is a synchrotron-based particle therapy center, able to extract accelerate and deliver subatomic particles beams (protons and carbon ions) for treatment of radio-resistant tumors. CNAO completed an experimental phase and started in 2014 the patient treatments within the national health system. To date CNAO has treated 3100 patients.
Main tasks attributed in the project
Contribution to WP1, WP11. Selection of eligible patients for the trial at multidisciplinary boards, PT of randomized patients, follow-up of trial patients after treatment.
About Institut Curie (IC)
Institut Curie is one of the leading medical, biological and biophysical research centers in the world. It is a private non-profit foundation operating a research center on biophysics, cell biology and oncology and a hospital specialized in treatment of cancer. The proton center is equipped with one gantry and two fixed beam rooms. It is located in Orsay, France.
Main tasks attributed in the project
Contribution to WP1, WP9, WP10, WP11. Selection of eligible patients for the trial at multidisciplinary tumor boards, dose distribution of patients treated by IMRT or IMPT, treatment of patients with IMRT, follow-up of trial patients after treatment. Proton beam therapy is performed in collaboration with CAL.
About The Centre Léon Bérard (CLB)
The Centre Léon Bérard (CLB) is part of the twenty French Comprehensive Cancer Centers, providing a global management of cancer patients on a unique site, from research to treatment. The Centre is a regional, national and international recognized reference cancer Centre assigned with three essential missions: Care, Research and Education and is dedicated to continuously improve the quality and accessibility of care for cancer patients. More than 30,000 patients are received each year, on consultations or exams and 6,000 new cancer cases are diagnosed. The CLB has technical and treatment facilities (operating rooms, radiation therapy center, medical imaging departments, pathology and nuclear medicine departments). The bench-to-bedside process is one of the strengths of the Centre Léon Bérard along with the pathology and NGS expertise. The Centre Léon Bérard develops an excellence and multidisciplinary research and innovative care and treatment, in collaboration with institutional and private partners. The foundations of this development lay in the medical and scientific project of the institution. The CLB aims to reinforce the bench-to-bedside process by facilitating translational research to help innovation and speed-up its access to patients for diagnoses and therapies. Biological resource Center has been certified NF-96 900, clinical research has been certified ISO 9001 since 2013 and is thus one of the strength of the Centre. Importantly, about 20% of patients are included in clinical trials, allowing patients to access innovative molecules or treatments. At the Centre Léon Bérard 1,800 persons work in care, research, education and supportive care, whose quality has been recognized by the COFRAC certification (number 8-3503). CLB is nationally recognized for its expertise as leader of the AURAGEN initiative (France Médecine Génomique 2025) specialized in genomics and for its role of reference center within the European Reference Network (ERN) EURACAN Horizon H2020 project (European sarcoma guidelines). Moreover, it holds a national excellence translational program from the French NCI (Institut National du Cancer INCa), the SIRIC LYriCAN (SIRIC) and also participated in the ICGC (International Cancer Genome Consortium) initiative which allowed detailed characterization of about 50 types and subtypes of tumors. CLB has 320 beds, 200 beds for homecare hospitalization and 11 operating rooms. It has one of the largest technical platforms in France with 8 accelerators, 6 in Lyon and 2 in Villefranche-sur-Saône. Six of the 8 accelerators are installed on the CLB site. These latest generation accelerators are composed of 4 classic accelerators, 1 tomotherapy and 1 Cyberknife® unique in Auvergne-Rhône-Alpes. The department also has a dedicated scanner for dosimetry, allowing the preparation of the treatment plan, as well interventional radiology approach. Proton beam therapy is performed in collaboration with Nice. Each year, the radiotherapy department receives more than 3,500 patients for outpatient radiotherapy treatments and more than 600 people for brachytherapy.
Main tasks attributed in the project
Patient screening and recruitment; treatment with proton beam therapy and radiotherapy; patient follow up.
About The Christie NHS Foundation Trust. (CHNT)
The Christie NHS Foundation Trust is one of the largest cancer treatment centres in Europe, and an international leader in cancer research and development. We are one of the leading centres in the UK for clinical trials and radiotherapy research. Treating more than 40,000 patients a year, we are the first UK centre to be officially accredited as a comprehensive cancer centre. The Clinical Research Facility (CRF) at The Christie is also one of four specialist units in Manchester for experimental research that make up the NIHR Manchester CRF, providing us with the dedicated space and expertise required to deliver intensive and complex studies in safe environment. The Christie continues to expand with the current building of the Paterson Redevelopment Project. The multi-million pound development will be led by The Christie on behalf of the Manchester Cancer Research Centre (MCRC), an internationally renowned and hugely successful partnership between The University of Manchester, Cancer Research UK and The Christie NHS Foundation Trust. In December 2018 The Christie became home to one of only two high energy NHS proton beam therapy (PBT) centres in the UK. We provide specialised treatment for UK patients with complex and hard-to-treat cancers who would otherwise be required to have this treatment abroad.