A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.
详细描述
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open and parallel group study.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proved diagnosis of locally advanced gastric cancer.
- •No evidence of distant metastases or peritoneal metastases.
- •Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
- •Eligible for radical gastrectomy with D2 lymphadenectomy.
- •Have not received cytotoxic chemotherapy or radiotherapy.
- •Written informed consent is obtained prior to commencement of trial treatment.
排除标准
- •Existence of distant metastasis or peritoneal metastasis during surgery (M1).
- •Any previous chemotherapy or radiotherapy
- •Active systemic infections
- •Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- •Female patients who are pregnant or breast feeding
研究组 & 干预措施
Without HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
干预措施: SOX neoadjuvant or postoperative chemotherapy (Drug)
Without HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
干预措施: D2 radical gastrectomy (Procedure)
With HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
干预措施: D2 radical gastrectomy (Procedure)
With HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
干预措施: SOX neoadjuvant or postoperative chemotherapy (Drug)
With HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
干预措施: Hyperthermic intraperitoneal chemotherapy (HIPEC) (Procedure)
结局指标
主要结局
overall survival
时间窗: 5 years
From the date of surgery to the date of death or to the end of follow-up
次要结局
- distant metastasis rate(5 years)
- peritoneal metastasis rate(5 years)
- local recurrence rate(5 years)
- complication rate(5 years)
- progression-free survival(5 years)
研究者
Bin Xiong, MD
Director of Gastrointestinal Surgery Department
Wuhan University