SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ... | NCT02396498

NCT02396498

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D2 radical gastrectomy+Systemic chemotherapy	Placebo Comparator	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.
D2 radical gastrectomy+HIPEC	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
HIPEC	Drug	Using cisplatin in HIPEC plus oral S-1	D2 radical gastrectomy+HIPEC

Outcomes Module

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 Outcomes

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.

Eligibility Module

Eligibility Criteria

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

ID	Term
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy