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| ID | Type | Description | Link |
|---|---|---|---|
| 08Z28 | Other Grant/Funding Number | Nanjing Military Region |
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Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.
Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEEOX group | Experimental | A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, oxaliplatin 100 mg/m2, etoposide 80 mg/m2, and pharmorubicin 30 mg/m2 were administered from the celiac artery on day 1. 80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle. |
|
| SOX group | Active Comparator | A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, patients received intravenous oxaliplatin 130 mg/m2 on day 1, and 80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group. |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year progression free survival | time period calculated from randomization to the first disease progression, recurrence or death from any cause | up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | the proportion of patients with complete and partial response according to Response Evaluation Criteria in Solid Tumors guidelines (version 1.1) | up to 4 years |
| R0 resection rate |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity analysis of primary outcome adjusted for stratification factors | up to 7 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoli Li, M.D. | Jinlin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Nanjing | Jiangsu | 210002 | China |
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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 |
|---|---|
| D000077150 | Oxaliplatin |
| D005047 | Etoposide |
| D015251 | Epirubicin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| etoposide | Drug | etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group. |
|
| pharmorubicin | Drug | pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group. |
|
|
| S-1 | Drug | 80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups. |
|
the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations
| up to 4 years |
| 3 year overall survival | time period calculated from randomization to death from any cause | up to 7 years |
| Adverse events of preoperative chemotherapy | preoperative chemotherapy associated complications | up to 4 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |