CMISG1701: a multicenter prospective randomized phase III clinical trial comparing neoadjuvant chemoradiotherapy to neoadjuvant chemotherapy followed by minimally invasive esophagectomy in patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0-1M0) (NCT03001596).
BACKGROUND
Neoadjuvant 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/DESIGN
CMISG1701 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.


DISCUSSION
The 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 REGISTRATION
NCT03001596 (December 17, 2016).
['Tang|Han|H|', 'Tan|Lijie|L|', 'Shen|Yaxing|Y|', 'Wang|Hao|H|', 'Lin|Miao|M|', 'Feng|Mingxiang|M|', 'Xu|Songtao|S|', 'Guo|Weigang|W|', 'Qian|Cheng|C|', 'Liu|Tianshu|T|', 'Zeng|Zhaochong|Z|', 'Hou|Yingyong|Y|', 'Yu|Zhentao|Z|', 'Jiang|Hongjing|H|', 'Li|Zhigang|Z|', 'Chen|Chun|C|', 'Lian|Changhong|C|', 'Du|Ming|M|', 'Li|Hecheng|H|', 'Xie|Deyao|D|', 'Yin|Jun|J|', 'Zhao|Naiqing|N|', 'Wang|Qun|Q|']
D000230:Adenocarcinoma D000293:Adolescent D000328:Adult D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D002294:Carcinoma, Squamous Cell D059248:Chemoradiotherapy D003131:Combined Modality Therapy D004938:Esophageal Neoplasms D016629:Esophagectomy D005260:Female D005500:Follow-Up Studies D006801:Humans D008297:Male D008875:Middle Aged D020360:Neoadjuvant Therapy D011379:Prognosis D011446:Prospective Studies D011788:Quality of Life D015996:Survival Rate D055815:Young Adult
Neoadjuvant chemotherapy Minimally invasive esophagectomy Neoadjuvant chemoradiation Esophageal esophageal squamous carcinoma