Abstract
BackgroundNeoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous cell carcinoma due to its significant postoperative mortality. However, it is assumed the combination of neoadjuvant chemoradiation with minimally invasive esophagectomy (MIE) may reduce postoperative mortality, which can revive preoperative chemoradiation. No randomized controlled studies comparing neoadjuvant chemoradiation plus MIE with neoadjuvant chemotherapy plus MIE have been performed so far. The present trial is initiated to obtain valid information whether neoadjuvant chemoradiation plus MIE yields better survival without worse postoperative morbidity and mortality in the treatment of locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).Methods/designCMISG1701 is a multicenter, prospective, randomized, phase III clinical trial, investigating the safety and efficacy of neoadjuvant chemoradiation plus MIE compared with neoadjuvant chemotherapy plus MIE. Patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0-1M0) are eligible for the study. A total of 264 patients are randomly assigned to neoadjuvant chemoradiation (arm A) or neoadjuvant chemotherapy (arm B) with a 1:1 allocation ratio. The primary outcome is overall survival assessed with a minimum follow-up of 36 months. Secondary outcomes are progression-free survival, recurrence-free survival, postoperative pathologic stage, treatment-related complications, postoperative mortality as well as quality of life.DiscussionThe objective of this trial is to identify the superior protocol with regard to patient survival, treatment morbidity/mortality and quality of life between neoadjuvant chemoradiation plus MIE and neoadjuvant chemotherapy plus MIE.Trial registrationNCT03001596 (December 17, 2016).
Highlights
Neoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous cell carcinoma due to its significant postoperative mortality
Traditional curative esophagectomy still plays an important role in the treatment of esophageal cancer, curative resection alone often accompanies with high recurrence and metastasis rates, low 3 and 5year overall survival, especially in patients with locally advanced resectable esophageal cancer(cT3-4aN0-1M0) [1]
The CROSS trial performed by van Hagen et al [3] was acknowledged as the most representative one among studies comparing neoadjuvant chemoradiation plus surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus
Summary
Neoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous cell carcinoma due to its significant postoperative mortality. The present trial is initiated to obtain valid information whether neoadjuvant chemoradiation plus MIE yields better survival without worse postoperative morbidity and mortality in the treatment of locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0). The CROSS trial performed by van Hagen et al [3] was acknowledged as the most representative one among studies comparing neoadjuvant chemoradiation (nCRT) plus surgery versus surgery alone for patients with adenocarcinoma or squamous cell carcinoma of the esophagus. Many studies [4,5,6,7] verified the fact that a significant overall survival benefit was achieved with nCRT plus surgery compared to surgery alone for patients with ESCC. Thereafter, nCRT has not been perceived as a safe approach, while neoadjuvant chemotherapy (nCT), which showed an improved survival rate compared with surgery alone, has been demonstrated safe by many studies [6, 9,10,11] and is being applied as an standard approach for treatment of ESCC
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
