A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.
详细描述
To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter 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 colorectal cancer.
- •No evidence of distant metastases or peritoneal metastases.
- •Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
- •Eligible for radical colorectal resection with 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
Radical colorectal resection without HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)
干预措施: Radical colorectal resection (Procedure)
Radical colorectal resection without HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)
干预措施: Oxaliplatin , Capecitabine (Drug)
Radical colorectal resection without HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX)
干预措施: Normal saline , Cisplatin , 5-Fu (Drug)
Radical colorectal resection with HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX)
干预措施: Hyperthermic intraperitoneal chemotherapy (HIPEC) (Procedure)
Radical colorectal resection with HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX)
干预措施: Radical colorectal resection (Procedure)
Radical colorectal resection with HIPEC
Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX)
干预措施: Oxaliplatin , Capecitabine (Drug)
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)
- progression-free survival(5 years)
- peritoneal metastasis rate(5 years)
- local recurrence rate(5 years)
- complication rate(5 years)
研究者
Bin Xiong, MD
Cancer Center of Wuhan University
Wuhan University