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Stage I:Neoadjuvant therapy
Stage II: Perioperative therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postoperative chemotherapy,SOX | Active Comparator |
| |
| Perioperative chemotherapy,SOX | Experimental |
| |
| Perioperative chemotherapy,XELOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin | Drug | Tegafur,Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival(DFS) | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | At the end of the study | |
| Disease control rate (DCR) | To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria | At the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
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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 |
|---|---|---|---|
| 37501640 | Derived | Ding P, Wu J, Wu H, Sun C, Meng M, Lowe S, Tian Y, Guo H, Meng L, Zhao Q. Comment on 'Hand grip strength-based cachexia index as a predictor of cancer cachexia and prognosis in patients with cancer' by Xie et al. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2449-2451. doi: 10.1002/jcsm.13298. Epub 2023 Jul 28. No abstract available. | |
| 32583567 |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005641 | Tegafur |
| C104201 | gimeracil |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 |
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|
| Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin | Drug | Tegafur,Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur,Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation |
|
|
| Oxaliplatin; Capecitabine | Drug | Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation |
|
|
| Down staging rate | After the pathological examination of resected specimen | Within 3 weeks after surgery |
| Overall survival (OS) | 5 year |
| Adverse events | 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. | Side effects during observation |
| R0-resection rate | After the pathological examination of resected specimen | Within 3 weeks after surgery |
| Zhao Q, Lian C, Huo Z, Li M, Liu Y, Fan L, Tan B, Zhao X, Zhang Z, Wang D, Liu Y, Guo H, Yang P, Tian Y, Li Y. The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial. Cancer Med. 2020 Aug;9(16):5731-5745. doi: 10.1002/cam4.3224. Epub 2020 Jun 24. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |