INTRODUCTION:Since 2017, in France, medical physicists (MP) are finally defined by law as health professionals and as such, the roles and responsibilities of an MP lean on those medical professional ethics but MPs lack initial or continuing training in this subject. In order to find out how our colleagues feel about this subject, the following survey was conducted. METHODS:French Society of Medical Physics (SFPM) designed a web survey addressed to its members and non-members concerning ethics based on the 2013 AAPM work; experience and training were highlighted as particularly important within the survey structure. RESULTS:249 answers were collected and showed a pronounced concern at the lack of initial and continuous training in this subject. Professional experience of non-ethical behaviour was attributed to the lack of training, resources or competences and hostile work environments. CONCLUSION:To address the shortcomings highlighted in the survey, SFPM has created a dedicated voluntary working group aimed at producing a professional code of ethics for MP and training modules to be applied at entry level or as continuing professional development for education.

Oligometastatic cancers designate cancers in which the number of metastases is less than five, corresponding to a particular biological entity whose prognosis is situated between a localized and metastatic disease. The liver is one of the main sites of metastases. When patients are not suitable for surgery, stereotactic body radiotherapy provides high local control rate, although these data come mainly from retrospective studies, with no phase III study results. The need for a high therapeutic dose (biologically effective dose greater than 100Gy) while respecting the constraints on the organs at risk, and the management of respiratory movements require expertise and sufficient technical prerequisites. The emergence of new techniques such as MRI-guided radiotherapy could further increase the effectiveness of stereotactic radiotherapy of liver metastases, and thus improve the prognosis of these oligometastatic cancers.

The EFOMP working group on the Role of Medical Physics Experts (MPEs) in Clinical Trials was established in 2010, with experts from across Europe and different areas of medical physics. Their main aims were: (1) To develop a consensus guidance document for the work MPEs do in clinical trials across Europe. (2) Complement the work by American colleagues in AAPM TG 113 and guidance from National Member Organisations. (3) To cover external beam radiotherapy, brachytherapy, nuclear medicine, molecular radiotherapy, and imaging. This document outlines the main output from this working group. Giving guidance to MPEs, and indeed all Medical Physicists (MP) and MP trainees wishing to work in clinical trials. It also gives guidance to the wider multidisciplinary team, advising where MPEs must legally be involved, as well as highlighting areas where MPEs skills and expertise can really add value to clinical trials.

Metastatic gastrointestinal cancer is not an uncommon situation, especially for pancreatic, gastric, and colorectal cancers. In this setting, few data are available on the impact of the treatment of the primary tumour. Oligometastatic disease is associated with longer survival in comparison with more advanced disease. Metastasis-directed therapy, such as stereotactic body radiotherapy, seems related to better outcomes, but the level of evidence is low. In most tumour locations, prospective data are very scarce and inclusion in ongoing trials is strongly recommended.

INTRODUCTION:The roles and responsibilities of medical physicists (MPs) are growing together with the evolving science and technology. The complexity of today's clinical trials requires the skills and knowledge of MPs for their safe and efficient implementation. However, it is unclear to what extent the skillsets offered by MPs are being exploited in clinical trials across Europe.METHODS:The EFOMP Working Group on the role of Medical Physics Experts in Clinical Trials has designed a survey that targeted all 36 current National Member Organisations, receiving a response from 31 countries. The survey included both quantitative and qualitative queries regarding the involvement of MPs in trial design, setup, and coordination, either as trial team members or principal investigators.RESULTS:The extent of MPs involvement in clinical trials greatly varies across European countries. The results showed disparities between the roles played by MPs in trial design, conduct or data processing. Similarly, differences among the 31 European countries that responded to the survey were found regarding the existence of national bodies responsible for trials or the available training offered to MPs. The role of principal investigator or co-investigator was reported by 12 countries (39%), a sign of efficient collaboration with medical doctors in designing and implementing clinical studies.CONCLUSION:Organisation of specific training courses and guideline development for clinical trial design and conduct would encourage the involvement of a larger number of MPs in all stages of trials across Europe, leading to a better standardisation of clinical practice.

Quality assurance for radiotherapy of a clinical trial is an important step from the design of the clinical trial. A precise definition of quality assurance must be given in detail in the clinical protocol of the clinical trial. By its implementation, quality assurance allows a homogeneity of the clinical trial, which can lead to a reduction of the biases of results interpretation for the clinical trial. The complexity of the radiotherapy to be carried out within the framework of the clinical trial can induce a gradation for the radiotherapy quality assurance program of the trial. However, the following steps are always present and must be described either directly in the clinical protocol or in a specific chapter, radiotherapy quality assurance, of the clinical protocol. The detailed characteristics of the medical imaging required to prepare for the treatment, the delineation of the targets and organs at risk, the requirements related to the planning, the treatment itself, possibly including the positioning repositioning control images, of the patient. For the delineation and planning stages, it is common to set up benchmarking based on test cases (dummy run, dry run). Their validation makes it possible for the center to get credentials for the clinical trial. Some trials can provide for an additional quality assurance point, such End-to-End test for which the investigating center must carry out, according to the clinical protocol, the preparation, the planning, the treatment on an anthropomorphic test object containing models of targets, organs at risk as well as dosimeters. Quality assurance of radiotherapy in clinical research is an essential part to be taken into account from the design of the clinical study. The commitment of the investigating center in terms of human and material resources in compliance with the protocol and in the quality assurance of the trial constitute a guarantee of limitation of the biases for the study and its interpretation, facilitating the answer of the scientific question asked by the trial.

Stereotactic body radiotherapy (SBRT) has become treatment option for localized prostate cancer but the evi-dence base remains incomplete. Several clinical studies, both prospective and retrospective, have been published. However, treatment techniques, target volumes and dose constraints lack consistency between studies. Based on the current available literature, the French Genito-Urinary Group (GETUG) suggests that: 1. Because large prospective trials are lacking, SBRT could not be considered as a standard, but could be proposed as an option after patients have been given appropriate information and counselling. 2. Good candidates for SBRT are patients of the favorable or intermediate favorable groups. 3. 5 fractions of 7.25 Gy, for a total prescribed dose of 36.25 Gy seems both safe and effective. 4. Volume of interest delineation (target volume and organs at risk) and margins, dose constraints and radiotherapy techniques that should be used are also discussed.

The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.

PURPOSE:To update the 2011 ESTRO-EFOMP core curriculum (CC) for education and training of medical physics experts (MPE)s working in radiotherapy (RT), in line with recent EU guidelines, and to provide a framework for European countries to develop their own curriculum.MATERIAL AND METHODS:Since September 2019, 27 European MPEs representing ESTRO, EFOMP and National Societies, with expertise covering all subfields of RT physics, have revised the CC for recent advances in RT. The ESTRO and EFOMP Education Councils, all European National Societies and international stakeholders have been involved in the revision process.RESULTS:A 4-year training period has been proposed, with a total of 240 ECTS (European Credit Transfer and Accumulation System). Training entrance levels have been defined ensuring the necessary physics and mathematics background. The concept of competency-based education has been reinforced by introducing the CanMEDS role framework. The updated CC includes (ablative) stereotactic-, MR-guided- and adaptive RT, particle therapy, advanced automation, complex quantitative data analysis (big data/artificial intelligence), use of biological images, and personalized treatments. Due to the continuously increasing RT complexity, more emphasis has been given to quality management. Clear requirements for a research project ensure a proper preparation of MPE residents for their central role in science and innovation in RT.CONCLUSION:This updated, 3rd edition of the CC provides an MPE training framework for safe and effective practice of modern RT, while acknowledging the significant efforts needed in some countries to reach this level. The CC can contribute to further harmonization of MPE training in Europe.

L’assurance qualité de la radiothérapie d’un essai clinique est une étape importante dès la conception de l’essai clinique. La définition précise de l’assurance qualité doit faire l’objet d’une description détaillée dans le protocole clinique de l’essai clinique. Par sa mise en œuvre l’assurance qualité permet une homogénéité de l’essai clinique pouvant conduire à une réduction des biais d’interprétation des résultats de l’essai clinique. La complexité de la radiothérapie à réaliser dans le cadre de l’essai clinique peut induire, une gradation dans le programme de l’assurance qualité radiothérapie de l’essai. Cependant, les étapes suivantes sont toujours présentes et doivent être décrites soit directement dans le protocole clinique soit dans un chapitre spécifique, d’assurance qualité radiothérapie, du protocole clinique. Les caractéristiques détaillées des imageries médicales de préparation du traitement demandées, la délinéation des cibles et des organes à risque, les exigences liées à la planimétrie, le traitement proprement dit comprenant éventuellement les images de contrôle de positionnement, repositionnement du patient. Pour les étapes de délinéation et de planimétrie il est fréquent de mettre en place un benchmarking à partir de cas tests (dummy run, dry run). Leurs validations permettent de certifier le centre de radiothérapie pour l’essai clinique. Quelques essais prévoient un point d’assurance qualité supplémentaire, nommé test global pour lequel le centre investigateur doit réaliser, selon le protocole clinique, la préparation, la planimétrie, le traitement sur un objet test anthropomorphe contenant des modèles de cibles, d’organes à risque ainsi que des dosimètres. L’assurance qualité de la radiothérapie en recherche clinique est une partie essentielle à prendre en compte dès le design de l’étude clinique. L’assurance de la qualité améliore les résultats et réduit les hétérogénéités. L’engagement du centre investigateur en termes de moyens humains et matériels dans le respect du protocole et dans l’assurance de qualité de l’essai clinique constituent une garantie de limitation des biais de l’étude, facilitant la réponse à la question scientifique posée par l’essai.

The purpose of this article is to describe the external irradiation process and updated recommendations of the French society for radiation oncology for patient follow-up.

Background Stereotactic Body Radiation Therapy (SBRT) is an innovative modality based on high precision planning and delivery. Cancer with bone metastases and oligometastases are associated with an intermediate or good prognosis. We assume that prolonged survival rates would be achieved if both the primary tumor and metastases are controlled by local treatment. Our purpose is to demonstrate, via a multicenter randomized phase III trial, that local treatment of metastatic sites with curative intent with SBRT associated of systemic standard of care treatment would improve the progression-free survival in patients with solid tumor (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases compared to patients who received systemic standard of care treatment alone. Methods This is an open-labeled randomized superiority multicenter phase III trial. Patients with up to 3 bone-only metastases will be randomized in a 1:1 ratio.between Arm A (Experimental group): Standard care of treatment & SBRT to all bone metastases, and Arm B (Control group): standard care of treatment. For patients receiving SBRT, radiotherapy dose and fractionation depends on the site of the bone metastasis and the proximity to critical normal structures. This study aims to accrue a total of 196 patients within 4 years. The primary endpoint is progression-free survival at 1 year, and secondary endpoints include Bone progression-free survival; Local control; Cancer-specific survival; Overall survival; Toxicity; Quality of life; Pain score analysis, Cost-utility analysis; Cost-effectiveness analysis and Budget impact analysis. Discussion The expected benefit for the patient in the experimental arm is a longer expectancy of life without skeletal recurrence and the discomfort, pain and drastic reduction of mobility and handicap that the lack of local control of bone metastases eventually inflicts. Trials registration ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study

The aim of this review is to present the specificities of clinical research in radiation oncology. Objectives are similar to all research in oncology: to improve the efficacy and to decrease toxic effects. Phase III trials remain the main methodology to demonstrate an improvement in efficiency, but phase I-II and registers are also important tools to validate an improvement in the therapeutic index with new technologies. In this article we discuss the special features of end-points, selection of population, and design for radiation oncology clinical trials. Quality control of delivered treatments is an important component of these protocols. Financial issues are also discussed, in the particular context of France.

The purpose of the first two editions of the guidelines for external radiotherapy procedures, published in 2007 and 2016 respectively, was to issue recommendations aimed at optimising, harmonising and standardising practices. The purpose of this third edition, which includes brachytherapy, is identical while also taking into account recent technological improvements (intensity modulation radiation therapy, stereotactic radiotherapy, and three-dimension brachytherapy) along with findings from literature. Part one describes the daily use of general principles (quality, security, image-guided radiation therapy); part two describes each treatment step for the main types of cancer.

PURPOSE:ESTRO-EFOMP intend to update the core curriculum (CC) for education and training of medical physicists in radiotherapy in line with the European Commission (EC) guidelines on Medical Physics Experts (MPE), the CanMEDS methodology and recent developments in radiotherapy. As input, a survey of the current structure of radiotherapy MPE national training schemes (NTS) in Europe was carried out. METHODS:A 35-question survey was sent to all European medical physics national societies (NS) with a focus on existence of an NTS, its format and duration, required entry-level education, and financial support for trainees. RESULTS:Twenty-six of 36 NS responded. Twenty had an NTS. Minimum required pre-training education varied from BSc in physics or related sciences (5/2) to MSc in medical physics, physics or related sciences (6/5/2) with 50-210 ECTS in fundamental physics and mathematics. The training period varied from 1 to 5 years (median 3 years with 50% dedicated to radiotherapy). The ratio of time spent on university lectures versus hospital training was most commonly 25%/75%. In 14 of 20 countries with an NTS, a research project was mandatory. Residents were paid in 17 of 20 countries. The recognition was mostly obtained by examination. Medical physics is recognised as a healthcare profession in 19 of 26 countries. CONCLUSIONS:The NTS entrance level, duration and curriculum showed significant variations. This survey serves to inform the design of the updated CC to define a realistic minimum training level for safe and effective practice aiming at further harmonization in line with EC guidelines.