Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Positive peritoneal lavage
研究概览
简要总结
This is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.
详细描述
In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity organs, peritoneal lavage will be performed followed by immunological examination. After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed, followed by immunological examination. Patients of this group will not receive intraoperative intra-abdominal chemotherapy. After performing the surgical intervention, the patient will perform irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual:
- •Histologically verified adenocarcinoma of the colon.
- •Signed informed consent.
排除标准
- •Pregnancy or lactation.
- •The presence of synchronous or metachronous malignant tumors.
- •Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs.
- •Neoadjuvant chemotherapy.
- •Suspected Lynch syndrome.
结局指标
主要结局
Positive peritoneal lavage
时间窗: through study completion, an average of 1 year
Cancer cell vitality
次要结局
未报告次要终点
研究者
Achkasov Sergey
Professor Sc.State Scientific Centre of Coloproctology, Head of Surgical department of sugery and oncology of colon, Moscow,Russian Federation
State Scientific Centre of Coloproctology, Russian Federation