An analysis of the on-going clinical trials on proton and heavy-ion radiation therapy and their impact on the clinical application and future development

Abstract

To perform an evaluation of the on-going prospective clinical trials on particle radiation therapy and their impact on the current clinical practice as well as future clinical research and development. Furthermore, to briefly present the results of the registration trial of the IONTRIS particle therapy system at the Shanghai Proton and Heavy Ion Center. We used data from the clinicaltrials.gov and the Particle Therapy Collaborative Organization Group (PTCOG) website. After excluding retrospective and in silico studies, we examined and analyzed the prospective clinical trials for their ion type, targeting disease site, and nature. At the time of this analysis, 149 prospective trials were identified on proton and carbon-ion radiation therapy, including 20 were carbon-ion and 129 trials were proton radiation focused, respectively. Except for 15 randomized phase Ⅱ/Ⅲ and Ⅲ trials, 134 trials were phase 0-Ⅱ trials. Tumors from nearly all body parts were covered by the on-going trials, but trials on pediatric, GI, lung, prostate, and breast cancer account for the majority. The majority of the currently on-going trials focus on the efficacy and adverse-effects of the new dose/fractionation schemes of particle therapy as well as the use of particle therapy on new indications. Few studies investigate the addition of adjuvant therapy or imaging technology used in adjunct with particle therapy. Randomized trials that compare particle radiation therapy versus photon radiation is relatively uncommon. Despite the prevailing use of proton and heavy-ion radiation therapy for cancer treatment, ~150 prospective clinical trials associated with particle radiation therapy are identified. As the majority of trials aim to investigate more efficacious dose/fractionation and the application of particle therapy on new indications, improved outcome from and expanded utilization of particle radiation therapy can be expected. Key words: Proton; Carbon ion; Radiotherapy