ABSTRACT
This chapter provides an update on the current status of clinical research with respect to particle therapy trials in Europe, the United States and Japan. There is no doubt that an randomised controlled trial (RCT) is the most appropriate study design when particle therapy is intended to increase treatment efficacy in terms of local control or survival by target dose escalation beyond the dose considered to be the current standard. Clinical trials involving particle therapy are complex, not only because of the technology itself but also because of the need for credentialing and quality assurance of participating institutions and investigators, and the need for funding. At present, most of the patients receiving CIRT in Japan visit National Institute for Radiological Sciences (NIRS) seeking CIRT in particular. A multi-institutional prospective randomised and/or nonrandomised concurrent phase II clinical trial is one such new approach.
