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Open Access 01-12-2020 | Esophageal Cancer | Study protocol

Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients: a prospective, multicenter clinical trial protocol

Authors: Xiao Chang, Lei Deng, Wenjie Ni, Chen Li, Weiming Han, Lin-rui Gao, Shijia Wang, Zongmei Zhou, Dongfu Chen, Qinfu Feng, Jun Liang, Nan Bi, Jima Lv, Shugeng Gao, Yousheng Mao, Qi Xue, Zefen Xiao

Published in: BMC Cancer | Issue 1/2020

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.govNCT03731442, Registered November 6, 2018.

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Title: Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients: a prospective, multicenter clinical trial protocol
Authors: Xiao Chang
Lei Deng
Wenjie Ni
Chen Li
Weiming Han
Lin-rui Gao
Shijia Wang
Zongmei Zhou
Dongfu Chen
Qinfu Feng
Jun Liang
Nan Bi
Jima Lv
Shugeng Gao
Yousheng Mao
Qi Xue
Zefen Xiao
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Esophageal Cancer
Esophageal Cancer
Published in: BMC Cancer / Issue 1/2020
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-020-07315-0

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Abstract

Background

Methods

Discussion

Trial registration

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