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gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.
Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLOT group | Experimental | 4 cycles preoperative chemotherapy with Docetaxel+oxaliplatin+s1 . Gastric resection. 6 cycles adjuvant chemotherapy with sequential oxaliplatin+s1 or oxaliplatin+s1,then s1 for 6 months。 |
|
| SOX group | Active Comparator | 3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel;oxaliplatin;s1 | Drug | Docetaxel 60mg/m2 was administered on day 1 of every 14 days.oxaliplatin 85 mg/m2 was administered on day 2 every 14 days. 40-60 mg of oral S-1 according to body-surface area twice a day was given for 10 days every 14 days . |
| Measure | Description | Time Frame |
|---|---|---|
| 5 year overall survival | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year relapse free survival | 5 years | |
| Surgical complete resection rate (R0) | 2.5 year | |
| Pathological response rate |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life questionnaire | 6 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Huang, M.D. | Contact | 8610-87788103 | huangjingwg@163.com | |
| Jing Huang, M.D | Contact | 8610-87788103 | huangjingwg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Huang, M.D. | Cancer Hospital, CAMS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
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| oxaliplatin;s1 | Drug | oxaliplatin 100 mg/m2 on day 1 every 21 days.40-60 mg of oral S-1 according to body-surface area twice a day was given for 2 weeks every 21 days . |
|
| 2.5 year |