International standardization of four dimensional radiotherapy system: Enhancement of effects of irradiation and assurance of safety

In radiation therapy for cancer, there are possibilities of position changes of the affected area during irradiation due to respiration of a patient. In order to enhance effects of irradiation for the affected area and minimize damages to the surrounding normal tissues, four dimensional radiotherapy (4DRT), which can take into account time variation of the three-dimensional position of the affected area, has been recently developed, and has been achieving significant therapeutic effects. We have proposed the International Electrotechnical Commission (IEC) standards including technical requirements of the safety aspects of the systems which realize this 4DRT, taking into account the time aspect. The reason for the proposal is that international standardization will be very effective to ensure safety of 4DRT, and international standards of IEC will have compelling force if regulatory agencies refer to them. The purpose of this paper is to summarize the analysis of the strategy in a precedent endeavor toward international standardization of the 4DRT systems, for which demands are increasing. The main point of the strategy is forming an international consensus by bringing together the opinions of specialists from various fields from a clinical point of view, focusing on the international standardization of the technical requirements of the safety aspects of the 4DRT. Based on such a strategy, we will promote developing new standards by evaluating the overall safety of the 4DRT systems for further expanding use, in addition to updating existing standards of particular equipment which constitute the 4DRT systems.