Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients:
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Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients: a prospective, multicenter clinical trial protocol Xiao Chang1†, Lei Deng1†, Wenjie Ni1, Chen Li1, Weiming Han1, Lin-rui Gao1, Shijia Wang1, Zongmei Zhou1, Dongfu Chen1, Qinfu Feng1, Jun Liang1, Nan Bi1, Jima Lv1, Shugeng Gao2, Yousheng Mao2, Qi Xue2 and Zefen Xiao1*
Abstract Background: Currently, adjuvant therapy is not recommended for patients with thoracic esophageal squamous cell cancer (TESCC) after radical surgery, and a proportion of these patients go on to develop locoregional recurrence (LRR) within 2 years. Besides, there is no evidence for salvage chemoradiation therapy (CRT) in patients with residual tumor after esophagectomy (R1/R2 resection). In addition, factors like different failure patterns and relationship with normal organs influence the decision for salvage strategy. Here, we aimed to design a modularized salvage CRT strategy for patients without a chance of salvage surgery according to different failure patterns (including R1/R2 resection), and further evaluated its efficacy and safety. Methods: Our study was designed as a one arm, multicenter, prospective clinical trial. All enrolled patients were stratified in a stepwise manner based on the nature of surgery (R0 or R1/2), recurrent lesion diameter, involved regions, and time-to-recurrence, and were further assigned to undergo either elective nodal irradiation or involved field irradiation. Then, radiation technique and dose prescription were modified according to the distance from the recurrent lesion to the thoracic stomach or intestine. Ultimately, four treatment plans were established. Discussion: This prospective study provided high-level evidence for clinical salvage management in patients with TESCC who developed LRR after radical surgery or those who underwent R1/R2 resection. Trial registration: Prospectively Registered. ClinicalTrials.gov NCT03731442, Registered November 6, 2018. Keywords: Esophageal neoplasm, Locoregional recurrence, R1/R2 resection, Chemoradiation therapy, Palliative management * Correspondence: [email protected] † Xiao Chang and Lei Deng are first authors responsible for paper writing and patients enrollment 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, No. 17 South Panjiayuan lane, Chaoyang District, 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 artic
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