A Randomized,Open-lable,Multicenter Trial Of XELOX Concurrent Chemoradiotherapy Versus Radical Operation For Local Advanced Esophageal Squamous Cell Cancer In Chinese Patients

Objective:A definitive concurrent chemoradiotherapy with four cycles of capecitabine combined with oxaliplatin(XELOX)or a radical surgery after neoadjuvant concurrent chemoradiotherapy were administered,respectively,on patients with locally advanced esophageal squamous cell carcinoma at stage of T1bN+M0~T2-4aN0-2M0,and the long-term survival,short-term therapeutic efficacy,safety and change of quality of life were compared between these two cohorts of patients.Methods:From June 1,2018 to March 15,2019,Patients with esophageal squamous cell carcinoma were recruited from multiple participating centers.The enrolled patients were randomly divided into the definitive concurrent chemoradiotherapy group(experimental group)and the radical surgery group(control group).The concurrent chemoradiotherapy group was performed XELOX program 4-cycle.The operation group received surgical treatment within 2 months after the end of 2 cycles of XELOX program concurrent chemoradiotherapy.Long-term survival,Short-term efficacy(tumor effective RR(CR+PR),disease control rate(RR+SD),incidence of adverse events and quality of life(QoL)were compared between the two groups.Chi-square test or Fisher precision test and T test were used to analyze the clinical data and test data.The methods above were analyzed through SPSS 23.0 statistical software.It showed a statistically significant difference as P < 0.05.Results:1.At present,22 patients have been enrolled in the study,2 patients were out of the group,all of 20 patients have completed the treatment and have been evaluated.There were 11 cases in experimental group and 9 cases in control group.In the experimental group,there were 1 case of complete response(CR),9 cases of partial response(PR)and 1 case of stable disease(SD),respectively.In the control group,9 cases all have reached R0 resection.2.The higher incidence of adverse events in the experiment group were leukopenia(81.8%),neutropenia(54.5%),anemia(63.6%),nausea(72.7%),anorexia(72.7%),Esophageal pain(63.6%).The incidence of fatigue(55.6%),fever(55.6%),constipation(55.6%)in the control group was higher than that in the experimental group.There was one patient with leukopenia and one patient with esophageal pain in the experiment group who had serious adverse events.One case of pulmonary infection and one case of postoperative diaphragmatic hernia were in the control group.However,there was no significant statistical difference.3.For the quality of life,the score of the experimental group decreased significantly after 4 cycles of definitive concurrent chemoradiotherapy,but the degree of decrease was more significant in the control group after operation.Conclusions:1.For patients with locally advanced esophageal squamous cell carcinoma,compared with concurrent chemoradiotherapy followed by surgery,definitive concurrent chemoradiotherapy with XELOX regimen had fewer adverse events and higher quality of life.2.Due to the small number of patients enrolled in the trial and the short follow-up period,we couldn’t perform a statistical analysis for the survival analysis and efficacy evaluation after radical treatment.It is necessary to further expand the number of cases,long-term follow-up,and ultimately a comprehensive assessment of the advantages and disadvantages of the two treatment options.