Esophagectomy Versus Definitive Chemoradiotherapy for Patients with Clinical Stage N0 and Pathological Stage T1b Esophageal Squamous Cell Carcinoma After Endoscopic Submucosal Dissection: Study Protocol for a Multicenter Randomized Controlled Trial...

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2020 Jul 3

PMID 32611448

Citations 5

Authors

Yang Yang

Yuchen Su

Xiaobin Zhang

Jun Liu

Hong Zhang

Bin Li

Rong Hua

Lijie Tan

Hezhong Chen

Zhigang Li

Affiliations

Soon will be listed here.

Abstract

Background: Esophagectomy is still advised as an additional treatment for pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER). ER followed with definitive chemoradiotherapy (dCRT) has shown increased quality of life as well as comparable oncological outcomes to esophagectomy. However, there is no well-designed phase III trial to compare the two treatments for patients with pT1b ESCC.

Methods: One hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers and randomly assigned to the esophagectomy group or the dCRT group. The clinical lymph node status will be measured by image examination, including computer tomography and positron emission tomography-computed tomography. The pathological tumor status will be diagnosed after endoscopic submucosal dissection (ESD). All patients will be followed up for 60 months after randomization. The primary endpoint is 5-year overall survival. The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates.

Discussion: To the best of our knowledge, this is the first phase III randomized controlled trial to compare esophagectomy and dCRT for patients with cN0-pT1b ESCC after ESD. Based on the results of this study, we will show whether dCRT will benefit patients more than esophagectomy, which will contribute more high-quality evidence to the primary salvage treatment for these patients.

Trial Registration: ClinicalTrials.gov, NCT04135664 . Registered on Aug. 10, 2019.

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