SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy
- Conditions
- Stage Ⅲ Gastric Cancer
- Interventions
- Drug: HIPEC
- Registration Number
- NCT02396498
- Lead Sponsor
- Tang-Du Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 270
- 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
-
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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D2 radical gastrectomy+HIPEC HIPEC 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.
- Primary Outcome Measures
Name Time Method DFS: Disease-Free Survival 2 years from the date of random to the date of recurrence or death for disease progression.
- Secondary Outcome Measures
Name Time Method OS: Overall Survival 5 years From the date of random to the date of death or to the end of follow-up
The quality of life 6 months The subjects should finish the quality of life scale by themselves before treament in every cycle.
Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0 6 months record and collect subjects' AE and SAE In the process of the total treatment according CTCAE4.0
Trial Locations
- Locations (1)
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China