Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- relapsed free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A
curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
干预措施: surgery (Procedure)
Arm A
curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
干预措施: adjuvant systemic chemotherapy (Drug)
Arm A
curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1
干预措施: Early postoperative intraperitoneal chemothgerapy (Drug)
Arm B
curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
干预措施: surgery (Procedure)
Arm B
curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1
干预措施: adjuvant systemic chemotherapy (Drug)
结局指标
主要结局
relapsed free survival
时间窗: postoperative 3 years
during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
次要结局
- overall survival(postoperative 5 years)
研究者
Wansik Yu
professor
Kyungpook National University Hospital