Lu Jiade,Kong Lin,Gao Jing,Jiang Guoliang.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[J].Chinese Journal of Radiological Medicine and Protection,2016,36(8):611-615
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
Received:March 24, 2016  
DOI:10.3760/cma.j.issn.0254-5098.2016.08.011
KeyWords:Proton  Carbon ion  Radiotherapy
FundProject:上海市自然科学基金(14ZR1407100);上海市申康医院发展中心临床科技创新项目(SHDC12015118)
Author NameAffiliationE-mail
Lu Jiade Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Shanghai 201315, China  
Kong Lin Fudan University Shanghai Cancer Center, Shanghai 201315, China  
Gao Jing Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Shanghai 201315, China  
Jiang Guoliang Fudan University Shanghai Cancer Center, Shanghai 201315, China guoliang.jiang@sphic.org.cn 
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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.
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