NAPTA: Optimizing clinical trial design & delivery of particle therapy for cancer

 描述（由申请人提供）：超过一半的癌症患者接受明确的放射治疗（RT），通常使用X射线。基于可以减少并发症和改善局部控制的假设，越来越多地使用具有低线性能量转移（LET）质子的粒子束放射治疗（PBRT）。高LET PBRT，例如，此外，碳和氖可以产生针对放射抗性和缺氧（氧合不良）肿瘤细胞的增加的有效性水平，所述肿瘤细胞代表最耐RT和化疗的侵袭性肿瘤细胞。患有晚期肺、头颈部、脑、食管和胰腺肿瘤的成人患者可能特别受益于高LET离子的优势，但迄今为止进行的研究尚未确定。为了证明开发具有高LET离子的昂贵PBRT设施的合理性，确定性研究（即，随机试验）来证明高LET离子束RT与使用低LET质子或基于先进X射线的治疗（例如调强放射（IMRT）或立体定向体放射治疗（SBRT））的治疗相比导致改善的结果。北美粒子治疗联盟（NAPTA）汇集了放射肿瘤学、医学和加速器物理学、磁体设计和放射生物学方面的专家，以及来自德国、意大利和日本现有离子束设施的国际顾问。NAPTA的主要目标是通过整合和开发所需的临床，生物和技术专业知识，在美国建立离子治疗的未来。在这最初的两年资助期内，我们将：1）组建一个具有共同愿景的团队网络，以进行PBRT的研发和临床研究; 2）通过开发所有合作机构共享的通用协议治疗所有患者的基础设施，加强PBRT的临床研究; 3）促进开发新的，低成本，紧凑/高效的离子加速器设计，离子加速器设计，离子加速 机架、治疗计划系统和成像技术;以及4）通过整合当前正在进行的项目和启动与使用质子和离子的现有设施的合作，促进与PBRT相关的放射生物学中的“新知识”的发展。

 DESCRIPTION (provided by applicant): More than half of all cancer patients receive definitive radiotherapy (RT), usually with x-rays. Particle beam radiation therapy (PBRT) with low linear energy transfer (LET) protons is increasingly being used based on the assumption they can reduce complications and improve local control. High-LET PBRT, e.g., with carbon ions, may provide additional physical dose distribution advantages over low-LET RT. In addition, carbon and neon may yield an increased level of effectiveness against radioresistant and hypoxic (poorly oxygenated) tumor cells, which represent the most RT- and chemotherapy-resistant aggressive tumor cells. Adult patients with advanced tumors of the lung, head and neck, brain, esophagus, and pancreas may especially benefit from the advantages of high-LET ions, but the studies conducted to date have not been definitive. To justify the development of an expensive PBRT facility with high-LET ions, definitive studies (i.e., randomized trials) are needed to prove that high-LET ion beam RT results in improved outcomes compared to treatment with low- LET protons or advanced x-ray based therapy such as intensity modulated radiation (IMRT) or stereotactic body radiotherapy (SBRT). The North American Particle Therapy Alliance (NAPTA) brings together experts in radiation oncology, medical and accelerator physics, magnet design, and radiobiology with international consultants from the existing ion beam facilities in Germany, Italy, and Japan. The main objective of NAPTA is to build a future for ion therapy in the U.S. by integrating and developing the required clinical, biological and technical expertise. In this initil two-year funding period, we will: 1) form a network of teams with a common vision for R&D and clinical studies involving PBRT; 2) enhance clinical PBRT research by developing the infrastructure for treating all patients within common protocols shared by all partner institutions 3) facilitate the development of new, low-cost, compact/efficient designs for ion accelerators, ion gantries, treatment planning systems, and imaging technology; and 4) facilitate the development of "new knowledge" in radiobiology related to PBRT, by integration of currently ongoing projects and startup of collaborations with access to existing facilities with protons and ions.