Stage Ⅲ Gastric Cancer
Conditions
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.
Interventions
DRUGHIPEC
Using cisplatin in HIPEC plus oral S-1
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS: Disease-Free Survival | 2 years | from the date of random to the date of recurrence or death for disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHelong Zhang, Professor
Outcome results
None listed