Clinical Study of the Impact of Hyperthermic Intraperitoneal Chemotherapy on Peritoneal Recurrence and Prognosis of Patients With Stage T4 Colorectal Cancer After Radical Surgery: A Multicentre Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 主要终点
- Incidence of endoperitoneal recurrence at 36 months
研究概览
简要总结
This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.
详细描述
Background:
Colorectal cancer (CRC) is the third most common malignancy worldwide, nearly 1.4 million new cases every year, for about 694000 deaths. Surgery is the primary treatment and results in a cure rate of approximately 50% of the patients. However, recurrence following surgery is a major problem, the second most common site of recurrence was peritoneum, which was as a result of the intraperitioneal free cancer cells (FCC) and microscopic cancer (MC). The remaining free cancers and microscopic cancer in abdominal cavity can not be killed completely because of the "peritoneal-plasma barrier" and "non-sufficient drug concentration in abdominal cavity by systemic venous chemotherapy". In recent years, hyperthermic intraperitioneal chemotherapy(HIPEC) has already been shown to be effective in improving the 5 year survival rate of colorectal cancer. However, lots of clinically studies for patients with colorectal cancer are advanced, it is not sure yet whether surgery combined with HIPEC is effective on decreasing the rate of peritoneal carcinomatosis in T4 stage colorectal cancer. The efficacy tend to be magnified when stage T4 patients account for less, confusing HIPEC for treatment of patients with advanced colorectal cancer. Therefore, the aim of this study is to investigate the clinical efficacy of HIPEC in T4 stage patients, ruling out the effects of different T stages on curative effect. The results of this study will hopefully provide the clinical basis for improving the prognosis of patients with advanced colorectal cancer.
Study design： This is a multicenter study in which 300 patients with T4 colorectal cancer will be randomized to surveillance alone (control group) or HIPEC (experimental group) after resection of the primary tumor, either by laparoscopy or open approach. Subsequently, all patients started mfolfox6 chemotherapy after operation in a month. Adverse reaction of chemotherapy during chemotherapy and post chemotherapy period will be recorded.
Study population:
The patients with colorectal cancer (T4N0-2M0) will undergo a curative resection by laparoscopy or open approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven colorectal adenocarcinoma
- •Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
- •Signed informed consent
- •White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
- •No bleeding diathesis or coagulopathy
- •Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial
排除标准
- •Liver and/or lung metastases
- •Pregnant women or likely to be pregnant
- •Severe hepatic and / or renal dysfunction
- •Impossibility of an adequate follow-up
- •Without history of cancer during last 5 years
- •Other concurrent chemotherapy
- •Severe or uncontrolled mental illness
- •Patients with epilepsy required to be treated
研究组 & 干预措施
surgery alone(open/laparoscopic)
The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic).
干预措施: Surgery without HIPEC (Procedure)
surgery and HIPEC
Standard surgical treatment and HIPEC with Lobaplatin.
干预措施: Surgery and HIPEC with Lobaplatin (Procedure)
结局指标
主要结局
Incidence of endoperitoneal recurrence at 36 months
时间窗: 36 months
次要结局
- Quality of life(3 years)
- HIPEC toxicity rate(6 month)
- Disease-free survival (DFS)(5 years)
- Overall survival (OS)(5 years)
研究者
Donglin Ren
MD
Sixth Affiliated Hospital, Sun Yat-sen University