A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/Capecitabine Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- radical resection rate
研究概览
简要总结
The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.
详细描述
To determine the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 colorectal cancer.
- •Unresectable peritoneal metastases and primary tumor proved at surgery.
- •No evidence of distant metastases.
- •Have not received radiotherapy, chemotherapy or immunotherapy.
- •ECOG score: 0~
- •Written informed consent is obtained prior to commencement of trial treatment.
排除标准
- •Existence of distant metastasis outside the abdomen.
- •Any previous radiotherapy, chemotherapy or immunotherapy.
- •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
Experimental
HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
干预措施: exploratory laparoscopy or laparotomy (Procedure)
Experimental
HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
干预措施: HIPEC (Procedure)
Experimental
HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
干预措施: Systemic chemotherapy (Drug)
结局指标
主要结局
radical resection rate
时间窗: 3 months
The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases
次要结局
- overall survival(3 years)
- complication rate(3 years)
- the Peritoneal Cancer Index score(3 months)
研究者
Bin Xiong, MD
Zhongnan Hospital
Wuhan University