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This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOX Sequential S-1 Group | Active Comparator | Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months |
|
| SOX Group | Active Comparator | Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months |
|
| TEGAFOX Sequential S-1 | Experimental | Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOX Sequential S-1 | Drug | 8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1:BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survial (OS) | Event driven, an expected average of 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survial | Event driven, an expected average of 24 months | |
| Safety (Adverse Events) | Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week |
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Inclusion Criteria:
Exclusion Criteria:
History of severe hypersensitivity reactions to the ingredients of S-1\TF\5-FU/calcium folinate or oxaliplatin
Inadequate hematopoietic function which is defined as below:
Inadequate hepatic or renal function which is defined as below:
Presence of peripheral neuropathy
Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
Psychiatric disorder or symptom that makes participation of the patient difficult;
Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months
Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Chen, MD | Contact | +86 0931-8942318 | chenxiaomd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Chen, MD | Second Hospital Affiliated to Lanzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Hospital Affiliated to Lanzhou University | Recruiting | Lanzhou | Gansu | 0931 | 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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| SOX | Drug | S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1:BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle |
|
| TEGAFOX Sequential S-1. | Drug | 6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1:BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle. |
|
| Dose intensity | Dose intensity will be used for present patients' compliance | Event driven, an expected average of 48 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |