Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer (EPIC-GC)

Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

National Cancer Center, Korea, Keimyung University Dongsan Medical Center, Yeungnam University Hospital, Daegu Catholic University Medical Center, Chonnam National University Hospital, Dong-A University Hospital, Severance Hospital, Korea Cancer Center Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Hanyang University

Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion. The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.

curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1

operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq

during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded

during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded

In hospital complication related to surgery or intraperitoneal chemotherapy will be recored and analyzed to evaluate the safety of intraperitoneal chemotherapy.

Inclusion Criteria: histologically proven adenocarcinoma of the stomach preoperative suspicion of serosal invasion on the radiological examination candidate for curative resection of the stomach with D2 age from 19 to 70 year old Eastern Cooperative Oncology Group Performance status :0, 1, or 2 absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and platelet≥100,000/microliter serum Creatinine<1.5mg/dL total bilirubin <2 x upper normal limit, transaminase<3 x upper normal limit patients without previous administration of chemotherapeutic agent patients who agreed and signed to the informed consent form Exclusion Criteria: malignancy of the stomach except for adenocarcinoma history of hypersensitivity to 5-fluorouracil or mitomycin concomitant infectious disease active hepatitis or chronic liver disease history of psychotic disorders patients with disorders in the central nervous system history of other malignancy within 5 years history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction) patients with increased bleeding tendency pregnant or lactating female patients patient who did not agreed and signed to the informed consent form

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