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This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer.
Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX | Active Comparator |
| |
| SOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium | Drug | FOLFOX: oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles SOX: oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival(PFS) | 3-year | |
| clinical response | 6 or 12 weeks | |
| pathological response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiren Yu | The First Affiliated Hospital of Medical School of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | China | |||
| Shandong Provincial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35226081 | Derived | Yu J, Gao Y, Chen L, Wu D, Shen Q, Zhao Z, Liu W, Yang H, Zhang Q, Wang X, Hu P, Zheng Z, Wang X, Liu H, Xu Z, Yan Z, Wu Y, Jin M, Zhang Q, Liu X, Zhu K, Shou C. Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220426. doi: 10.1001/jamanetworkopen.2022.0426. |
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|
| within 10 days after surgery |
| Number of Participants with grade 3/4 adverse Events | 6 Years |
| Jinan |
| Shandong |
| China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of Medical School of Zhejiang University | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Medical School of Zhejiang University | Hangzhou | Zhejiang | China |
| Jiaxing First Hospital | Jiaxing | Zhejiang | China |
| Ningbo Medical Treatment Center Lihuili Hospital | Ningbo | Zhejiang | China |
| The second affiliated hospital of Wenzhou medical college | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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