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Stage I:preoperative therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postoperative chemotherapy,XELOX | Active Comparator |
| |
| Preoperative Concurrent Chemoradiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin; Capecitabine | Drug | Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival(DFS) | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| R0-resection rate | within 3 weeks after surgery | |
| Objective response rate (ORR) | within 3 weeks after surgery | |
| Disease control rate (DCR) |
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Inclusion Criteria:
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;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qun Zhao, Doctor | Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery | Shijiazhuang | Hebei | 050011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34858829 | Derived | Tian Y, Wang J, Qiao X, Zhang J, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Yang P, Zhao Q. Long-Term Efficacy of Neoadjuvant Concurrent Chemoradiotherapy for Potentially Resectable Advanced Siewert Type II and III Adenocarcinomas of the Esophagogastric Junction. Front Oncol. 2021 Nov 11;11:756440. doi: 10.3389/fonc.2021.756440. eCollection 2021. |
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|
| Oxaliplatin; Capecitabine; concurrent radiotherapy | Other | Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT |
|
|
| within 3 weeks after surgery |
| Down-staging Rate | within 3 weeks after surgery |
| Overall survival (OS) | 3years |
| Adverse events | Side effects during observation] Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit. | 3 year |
| Death related to operation | 4 weeks |
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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