A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: SOX Sequential S-1
* Drug: SOX
* Drug: TEGAFOX Sequential S-1.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 75≧Age≧18 Histologically or cytologically confirmed gastrointestinal cancer Stage Ⅱ or Ⅲ or Ⅳ ECOG ≦2 Accept the gastric cancer radical resection Life expectancy of at least three months Written informed consent to participate in the trial 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: white blood cell (WBC) less than 5x10^9/L absolute neutrophil count (ANC) less than 2x10^9/L platelets less than 100*10^9/L Inadequate hepatic or renal function which is defined as below: serum bilirubin greater than 2 times the upper limit of normal range alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases blood creatinine level greater than 2 times ULN 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SOX Sequential S-1 Group<br>Patients received chemotherapy with oxaliplatin+ S-1  for 6 months and sequential S-1 for 6 months | Drug: SOX Sequential S-1<br>* 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.<br>|
| Active Comparator: SOX Group<br>Patients received chemotherapy with oxaliplatin+ S-1  for 12 months | Drug: SOX<br>* 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<br>|
| Experimental: TEGAFOX Sequential S-1<br>Patients received chemotherapy with TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium)  for 6 months and sequential S-1 for 6 months | Drug: TEGAFOX Sequential S-1.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survial (OS) |  | Event driven, an expected average of 48 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Dose intensity | Dose intensity will be used for present patients' compliance | Event driven, an expected average of 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, Adjuvant Chemotherapy, TEGAFOX