A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radio
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A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol Lin-rui Gao1, Xin Wang1, Weiming Han1, Wei Deng1, Chen Li1, Xiaomin Wang2, Yidian Zhao2, Wenjie Ni1, Xiao Chang1, Zongmei Zhou1, Lei Deng1, Wenqing Wang1, Wenyang Liu1, Jun Liang1, Tao Zhang1, Nan Bi1, Jianyang Wang1, Yirui Zhai1, Qinfu Feng1, Jima Lv1, Ling Li3* and Zefen Xiao1*
Abstract Background: Since the development of three-dimensional conformal radiotherapy and intensity-modulated radiotherapy (IMRT), no prospective study has investigated whether concurrent chemoradiotherapy (SIB-IMRT with 60 Gy) remains superior to radiotherapy (SIB-IMRT) alone for unresectable esophageal cancer (EC). Furthermore, the optimal therapeutic regimen for patients who cannot tolerate concurrent chemoradiotherapy is unclear. We recently completed a phase I/II radiation dose-escalation trial using simultaneous integrated boost (SIB), elective nodal irradiation, and concurrent chemotherapy for unresectable EC. We now intend to conduct a prospective, phase III, randomized study of SIB-IMRT with or without concurrent chemotherapy. We aim to find a safe, practical, and effective therapeutic regimen to replace the conventional segmentation (1.8– 2.0 Gy) treatment mode (radiotherapy ± chemotherapy) for unresectable EC. (Continued on next page)
* Correspondence: [email protected]; [email protected] 3 Department of Oncology, Affiliated Tengzhou Central People’s Hospital of Jining Medical University, Jining Medical University, Tengzhou 277599, China 1 Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to
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