Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer

A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy

The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.

Inclusion Criteria:

• 18 < age ≤ 65 years old
• Male or Non pregnant female
• The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
• Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
• Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
• White blood cells > 4,000/mm3
• neutrophils ≥ 1,500/mm3
• platelets ≥ 100,000/mm3
• hemoglobin>9g/l
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)
• total bilirubin (TBIL) < 1.5 times ULN
• serum creatinine < 1 times ULN
• Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

• Existence of macroscopic peritoneal implants
• Prior malignant tumors with detectable signs of recurrence or distant metastasis
• Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
• Receiving other cytotoxic chemotherapy
• High grade of intra-abdominal adhesions
• Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent