Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.

Inclusion Criteria:

• Pathologically diagnosed as gastric adenocarcinoma
• Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
• HER-2 negative tumor
• Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
• Absolute Neutrophil Count: ≧ 1,500/mm³
• Hemoglobin level: ≧ 8.0g/dL
• Platelet Count: ≧ 10×104/mm³
• AST (GOT), ALT (GPT): ≦ 100U/L
• Total Bilirubin: ≦ 2.0mg/dL
• Creatinine Clearance (CCl): ≧ 50mL/min
• ECOG 0 - 2

Exclusion Criteria:

• Patients with other major medical disease or malignant tumors other than gastric cancer
• Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
• Pregnant, breast-feeding women or with birth plan
• History of gastrointestinal surgery
• Patients refusing treatment