Adenocarcinoma of the Esophagogastric Junction
Conditions
Interventions
test group:preoperative radiochemotherapy+surgeron+adjuvantchemotherapy
control group:surgeron+adjuvant chemotherapy
Sponsors
Hebei Medical University affiliated Fourth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Disease must be clinically limited to the esophagogastric junction, defined Type II, Type III (From the endoscopic point of view according to the AEG criteria); 2. Histologically confirmed primary adenocarcinoma; 3. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0; 4. ECOG performance status <=2; 5. 18-75years; AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia. The classification of AEG type I, type II and type III AEG type I: adenocarcinoma of the distal esophagus, which usually arises from an area with specialized intestinal metaplasia of the esophagus, i Barrett's esophagus, and may infiltrate the esophago-gastric junction from above; (1) AEG type II: true carcinoma of the cardia, arising from the cardia epithelium or short segments with intestinal metaplasia at the esophago-gastric junction; (2) AEG type III: subcardial gastric carcinoma, which infiltrates the esophago-gastric junction and distal esophagus from below.
Exclusion criteria
Exclusion criteria: 1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning; 2. Patients with primary carcinomas of the esophagus; 3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery; 4. Patients with evidence of metastatic disease are not eligible; 5. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication; 6. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements; 7. Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study; 8. History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years Disease-free survival(DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| R0-resection rate;Objective response rate (ORR);Disease control rate (DCR);Down-staging Rate;3-years over survival rate; | — |
Countries
China
Contacts
Public ContactQun Zhao
Outcome results
None listed