A Multi-center,Open,Randomized Trial Of Capecitabine Alone Definitive Concurrent Chemoradiotherapy Versus Radical Surgury For Treatment Of Esophageal Squamous Cell Carcinoma In China

Objective:For patients with locally advanced esophageal squamous cell carcinoma,concurrent chemoradiotherapy and surgery are the two most important treatments.To explore a more suitable treatment plan for patients with esophageal squamous cell carcinoma in China,this study selected capecitabine as a chemotherapy drug,locally advanced esophageal squamous cell carcinoma were treated with definitive concurrent chemoradiotherapy or radical surgery,the efficacy,safety and quality of life of the two regimens were compared.Methods:From July 2018 to March 2019,patients with newly diagnosed non-cervical esophageal squamous cell carcinoma who were diagnosed by biopsy were enrolled in a multi-center clinical trial.The patients enrolled in the study were randomly divided into two groups.The experiment group received cicitabine single-agent concurrent chemoradiotherapy,the control group received capecitabine single-agent neoadjuvant radiotherapy combined with esophageal cancer radical surgery.The general clinicopathological characteristics of the patients were recorded at the time of enrollment.Hematological and imaging examinations were performed regularly during the treatment,and adverse events were recorded.Patients in the concurrent chemoradiotherapy group were evaluated for efficacy at the end of treatment.Patients in the surgical group were assigned R0 resection rate according to postoperative pathology.All patients were evaluated for quality of life after enrollment,treatment for9 weeks,and treatment for 16 weeks.Comparing the quality of life of the two groups of patients.Statistical analysis using SPSS22.0 software,P < 0.05 indicates that the difference is statistically significant.Results:1.Currently,16 patients were enrolled,and the patients were from Anyang Cancer Hospital,Nanyang Central Hospital and the First Affiliated Hospital of Henan University of Science and Technology.Of the 16 patients,10 were radical concurrent radiotherapy and chemotherapy,and 6 were neoadjuvant chemoradiotherapy combined with surgery.The 16-week efficacy evaluation of 10 patients in the concurrent chemoradiotherapy group was 6 PR and 4 CR;5 of the 6 patients in the operationgroup had completed the operation,and the pathological findings showed R0 resection.2.There were 15 statistical adverse events in the two groups.The higher incidence was esophageal pain,leukopenia,nausea,fever,constipation and so on.There were no serious adverse events in the patients undergoing concurrent radiotherapy and chemotherapy.One patient in the operation group developed septum after surgery and was given a second operation,which was a serious adverse event.There was no significant difference in adverse events between the two groups(P<0.05).3.In terms of quality of life,during the comparison,the quality of life of both groups of patients decreased temporarily during the treatment.After the end of treatment,the quality of life of the two groups of patients was compared,and the concurrent radiotherapy and chemotherapy group was superior to the surgery group.Conclusion:For patients with locally advanced esophageal squamous cell carcinoma:1.The clinical efficacy and control rate of capecitabine single-agent radical concurrent chemoradiotherapy is good.The R0 resection rate of capecitabine single-agent neoadjuvant therapy is higher,and there is no significant difference between the two regimens in adverse events.2.At the end of treatment,patients in the capecitabine radical concurrent radiotherapy and chemotherapy group were superior to the surgical group in quality of life.Due to the small number of patients currently enrolled and the short end of treatment,statistical analysis of survival is not possible.The next step is to continue to expand the number of cases,while long-term follow-up,compare the difference in survival between the two treatment options.