NCT02399410已完成2 期
BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- surgical morbidity and mortality
研究概览
简要总结
The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
- •absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
- •resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
- •complete macroscopic cytoreduction at the time of surgery (CC-0/1)
- •good general health status (Karnofsky index > 70%)
- •expected life expectancy more than 6 months
- •no other malignancy than disease under study
- •serum creatinine < 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
- •serum total bilirubin < 1.5 mg/dl
- •platelet count > 100,000/ml
- •hemoglobin > 9g/dl
- •neutrophil granulocytes > 1,500/ml
- •International Normalized Ration (INR) 2 or < 2
- •Absence of alcohol and/or drug abuse
- •No inclusion in other clinical trials interfering with the study protocol
- •No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Absence of heart failure (NYHA 2 or > 2) or significant coronary artery disease
- •No pregnancy or breast feeding
- •Adequate contraception in fertile patients
排除标准
- •No written informed consent
- •tumour in the presence of obstruction
- •evidence of extra-abdominal disease or extensive liver metastasis
- •peritoneal cancer index > 25
- •active bacterial, viral or fungal infection
- •active gastro-duodenal ulcer
- •parenchymal liver disease (any stage cirrhosis)
- •uncontrolled diabetes mellitus
- •severe obstructive or restrictive respiratory insufficiency
- •psychiatric pathology capable of affecting comprehension and judgment faculty
- •Known allergy to oxaliplatin
研究组 & 干预措施
bevacizumab and CRS with oxaliplatin
Experimental
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
干预措施: perioperative chemotherapy plus bevacizumab (Drug)
bevacizumab and CRS with oxaliplatin
Experimental
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
干预措施: cytoreductive surgery (Procedure)
bevacizumab and CRS with oxaliplatin
Experimental
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
干预措施: Intraperitoneal Oxaliplatin (Drug)
结局指标
主要结局
surgical morbidity and mortality
时间窗: until 3 months after surgery and intraperitoneal chemotherapy
This will be estimated with the Dindo-Clavien classification
次要结局
- progression free survival(24 months after finishing the adjuvant chemotherapy)
- treatment completion rate(day 1 after termination of adjuvant chemotherapy)
- overall survival(24 months after finishing the adjuvant chemotherapy)
- chemotherapy-related toxicity(1 month after termination of the adjuvant chemotherapy)
- pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab(day 1 after termination of the cytoreductive surgery)
研究者
研究点 (1)
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