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

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

doi:10.1186/s12885-020-07315-0

Abstract

BackgroundCurrently, 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.MethodsOur 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.DiscussionThis 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 registrationProspectively Registered. ClinicalTrials.govNCT03731442, Registered November 6, 2018.

Highlights

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
According to the 2019 National Comprehensive Cancer Network (NCCN) guidelines for esophageal cancer [1], adjuvant treatment is not recommended for patients with thoracic esophageal squamous cell cancer (TESCC) who received radical surgery as their first treatment, regardless of the T and N status
Radiation oncologists may find it difficult to screen patients with potential curative possibilities according to failure patterns and recurrence time to attain better patient survival

Summary

Introduction

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. There is no evidence for salvage chemoradiation therapy (CRT) in patients with residual tumor after esophagectomy (R1/R2 resection). 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. In patients with residual tumor (R1/R2), salvage chemoradiation therapy (CRT) is recommended as the main component of palliative management for locoregional recurrence (LRR) disease. Overall survival (OS) directly depended on failure patterns and corresponding treatment strategies, so prospective clinical trials were necessary for screening of specific patients to attain survival benefit from the optimal salvage strategy

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