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

Tang-Du Hospital

Status and phase: Unknown; Phase 3

Conditions: Stage Ⅲ Gastric Cancer

Treatments: Drug: HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT02396498

TDCCC005

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups, including a placebo group

D2 radical gastrectomy+Systemic chemotherapy

Placebo Comparator group

Description:

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 group

Description:

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.

Treatment:

Drug: HIPEC