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Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0,aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiation | Active Comparator | weekly 5-Fu and oxaliplatin |
|
| FLOT | Experimental | Eight perioperative chemotherapy cycles |
|
| FOLFOX | Experimental | Twelve perioperative chemotherapy cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemoradiation with weekly 5Fu and oxaliplatin | Radiation | 5Fu 225 mg/m2 IV daily continuous infusionï¼›oxaliplatin 40 mg/m2/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 year of disease free survival | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| 5 year of overall survival | 5 year | |
| Rate of pathological complete remission | 1 year | |
| Anastomosis leak rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanshan Li, MD | Contact | 86-20-38285497 | lishsh89@163.com | |
| Xiaohui Zhai, MD | Contact | 86-20-38285497 | zhaixh@zju.edu.cn |
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| Perioperative mFLOT | Drug | Perioperative docetaxel 50mg/m2ï¼›oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles |
|
| Perioperative FOLFOX | Drug | Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles |
|
| 1 year |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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