SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy

Study Overview
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Brief Summary
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The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy

Detailed Description
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The study is a randomized clinical trial，and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.

Official Title
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S-1 With Cisplatin Intravenous Chemotherapy Versus S-1 Plus Cisplatin Hyperthermic Intraperitoneal Chemotherapy in Stage Ⅲ Patients After D2 Gastrectomy：a Randomized Controlled Study

Conditions
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Stage Ⅲ Gastric Cancer

Intervention / Treatment
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* Drug: HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 ≤ age ≤ 70 years old Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted therapy , etc. The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 Having given written informed consent prior to any procedure related to the study Expected survival time ≥3 months Exclusion Criteria: History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin Hemoglobin<90g/L Inadequate hematopoietic function which is defined as below: white blood cell (WBC) less than 3,500/mm^3 absolute neutrophil count (ANC) less than 1,500/mm^3 platelets less than 80,000/mm^3 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 1.5 times ULN,Creatinine clearance<60ml/min 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 Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes Known DPD deficiency Participate in other clinical trial before the start of this trial Patient compliance is bad or researchers believe that patients are not suitable for this treatment Known to have active hepatitis patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: D2 radical gastrectomy+Systemic chemotherapy<br>8 cycles of systemic chemotherapy were performed for stage Ⅲ patients after D2 gastrectomy .Systemic chemotherapy(SP): Cisplatin: 60mg/m^2, d1 , Intravenous infusion, every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks .Subjects should be given maximum 8 cycles, or progression/intolerance. | |
| Experimental: D2 radical gastrectomy+HIPEC<br>8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after D2 radical gastrectomy. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance. | Drug: HIPEC<br>* Using cisplatin in HIPEC plus oral S-1<br>* Other names: hyperthermic intraperitoneal chemoperfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS: Disease-Free Survival | from the date of random to the date of recurrence or death for disease progression. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS: Overall Survival | From the date of random to the date of death or to the end of follow-up | 5 years | 
| The quality of life | The subjects should finish the quality of life scale by themselves before treament in every cycle. | 6 months | 
| Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0 | record and collect subjects' AE and SAE In the process of the total treatment according CTCAE4.0 | 6 months |