Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis - French Part of the Main Bev-IP Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification
研究概览
简要总结
Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients. The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.
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 85 Years（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 m2
- •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
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
干预措施: bevacizumab and HIPEC (Oxaliplatin 360 mg/m2). (Drug)
Bevacizumab and CRS with oxaliplatin
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
干预措施: Cytoreductive surgery combined with HIPEC (Procedure)
结局指标
主要结局
Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification
时间窗: Until 3 months after surgery and intraperitoneal chemotherapy
Major morbidity (grade IIIb or higher grade complication according to Dindo-Clavien classification)
次要结局
- Overall survival(24 months after finishing the adjuvant chemotherapy)
- Pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab(Day 1 after termination of the cytoreductive surgery)
- Number of participants with treatement related Adverse events less than grade IIIb as assessed by Dindo-Clavien classification(Until 3 months after surgery and intraperitoneal chemotherapy)
- Potential chemotherapy related morbidity(During the first 60 postoperative days)
- Quality of life assessment(24 months after finishing the adjuvant chemotherapy)
- Treatment completion rate(Day 1 after termination of adjuvant chemotherapy)
- Progression free survival(24 months after finishing the adjuvant chemotherapy)