https://journals.accscience.com/index.php/TD/issue/feed 2023-05-18T09:55:49+08:00 Tumor Discovery Editor editor.td@accscience.com Open Journal Systems https://journals.accscience.com/index.php/TD/article/view/342 2023-05-18T09:55:49+08:00 Jiali Song songjl@bjmu.edu.cn Zhiwei Rong rongzhiwei@bjmu.edu.com Xinwen Zhong cindy_zhongxinwem@126.com Yuhong Lu 2719836467@qq.com Jike Huang 1710306227@pku.edu.cn Yipei Yu yipei@bjmu.edu.cn Zhilin Liu liuzhilin@pku.edu.cn Xuyuan Quan houyan@bjmu.edu.cn Nana Chen houyan@bjmu.edu.cn Kang Li likang@ems.hrbmu.edu.cn Fengyu Sun sun.129.com@163.com Yan Hou houyan@bjmu.edu.cn

<p>There is great interest in accelerating late-stage therapy development by efficiently performing a trial design with multiple therapies or multiple subpopulations simultaneously under a single protocol. The master protocols are termed to describe the design of such trials, with a variety of terms such as umbrella, basket, or platform describing specific designs, which are, in contrast to the traditional trial designs, full of complexity. What should we consider in designing a trial ensuring the safety of human subjects and demonstrating the efficacy of new therapy? This paper overviews the master protocol framework, comprehensively unifies the definitions and illustrates essential design elements of representative example trials conducted in drugs and medical devices. Besides, to understand the master protocols deeply, it is also a need to summarize the commonly-used types of master protocols in various disease and treatment fields, along with the reasons for these phenomena by analyzing the characteristics of the diseases, the mechanism of therapeutic products, and the principles of various types of master protocols. Finally, we also propose practical considerations, including the design, ethical, statistics, and funding considerations that arise from implementing complex master protocols to help practitioners better design and identify potential valuable therapies.</p>

2023-04-28T13:04:23+08:00 Copyright (c) 2023 Author(s) https://journals.accscience.com/index.php/TD/article/view/356 2023-05-18T09:55:49+08:00 Marco Lorenzo Bonù marco.bonu@unibs.it Eneida Mataj e.mataj@unibs.it Jacopo Balduzzi j.balduzzi@unibs.it Maria Teresa Cefaratti m.cefaratti@unibs.it Gloria Pedersoli g.pedersoli005@unibs.it Gianluca Cossali e.mataj@unibs.it Luca Triggiani e.mataj@unibs.it Davide Tomasini e.mataj@unibs.it Michela Buglione e.mataj@unibs.it Stefano Maria Magrini stefano.magrini@unibs.it

<p>Here, we report the clinical case of a 44-year-old lady, affected by synovial sarcoma (SS) of the mediastinum which was treated in 2014, and relapsed in the upper abdomen in 2020. SS is a relatively radioresistant disease, radiotherapy (RT) is routinely reserved for the neoadjuvant/adjuvant or palliative context. In our scenario, stereotactic RT consisting in 45Gy in 6 fractions was proposed to manage the upper abdominal relapse. Exploiting simultaneous integrated protection, a deliberated reduction in the dose prescription in area of planning target volume overlapped with stomach was achieved, obtaining reasonable dosimetric goals. Acute toxicity in the patient was acceptable, and she did not experience late toxicity and was still free from disease, as noted in last follow-up, 15 months after treatment.</p>

2023-05-10T11:42:52+08:00 Copyright (c) 2023 Author(s)