A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery

Study Overview
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Brief Summary
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To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less toxicity.

Official Title
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Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: S-1
* Drug: oxaliplatin
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th) without previous treatment, including radiotherapy, chemotherapy and immunotherapy Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L creatinine≤1 UNL total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL ECOG score 0 - 2 take chemotherapy for 8 weeks after surgery older than 18 years can be followed up, good compliance can take medicine orally having signed informed consent Exclusion Criteria: combined disease lead to Life Expectancy less than 3 years any evidence to show metastasis,including cancer cells in peritoneal fluid inability to take oral medication for difficult to swallow, intestinal obstruction，active intestinal blooding or perforation previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone） operation within 4 weeks, or not recovered from last major operation allergy with fluorouracil allergy with Platinum or any composition in research drugs uncontrollable seizure disorder，central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction. pregnancy， lactation， women in child-bearing period and her spouses reject to take effictive method to conraception other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex（DTRs）. serious complicated infection or other complicated diseases and hard to controll. As one of belowing: ANC < 2×109/L Platelet<100×109/L total bilirubin>1.5 UNL ALAT、ASAT > 2.5 x ULN ALP> 2.5 x ULN Any investigational agent within the past 28 days. That is the patient had jioned another trial.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1+oxaliplatin<br>S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles. | Drug: S-1<br>* Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles<br>* Other names: Aisiwan;Drug: oxaliplatin<br>* Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles<br>|
| Active Comparator: S-1+cisplatin<br>S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles. | Drug: S-1<br>* Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles<br>* Other names: Aisiwan;Drug: cisplatin<br>* Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| replase free survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 6 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, D2 surgery, S-1, Oxaliplatin, cisplatin