Anatomical Resection Versus Nonanatomical Resection for Colorectal Liver Metastases Patients With Gene Mutation or Right-sidedness: The ARCLAMP Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- relapse-free survival
研究概览
简要总结
In this study, colorectal cancer patients with initially resectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with gene mutant or right-sidedness will be randomised between anatomical resection (AR) or nonanatomical resection (NAR). The primary end-point is the relapse-free survival.
详细描述
This study is a prospective, single-center, randomized control trial. The major including criteria are (1) Histologically confirmed colorectal cancer initially resectable liver-only metastases ; (2) patient has the opportunity to perform either anatomical resection (AR) or nonanatomical resection (NAR) surgery; (3) the number of metastasis is 1-3; (4) KRAS/NRAS/BRAF mutation or right-sidedness. Patients will be randomised between AR or NAR. Patients will be stratified for gene mutation and right-sidedness.
Based upon the segmental anatomy of the liver according to Couinaud system, AR is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof. NAR, also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.
The primary end-point is the relapse-free survival. The secondary end-points are postoperative complication, postoperative mortality, hospital length of stay, and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 and ≤ 75 years;
- •Histological proof of colorectal adenocarcinoma;
- •Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT);
- •Suitable for anatomical or nonanatomical liver resection (determined by a local MDT);
- •Number of metastasis is 1 to 3;
- •KRAS/NRAS/BRAF mutation or right-sidedness;
- •Performance Status (ECOG) 0~1;
- •Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization);
- •Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
- •Written informed consent.
排除标准
- •Previous systemic treatment for metastatic disease;
- •Previous surgery for metastatic disease;
- •Extrahepatic metastases;
- •Unresectable primary tumor;
- •Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
- •Second primary malignancy within the past 5 years;
- •Acute or subacute intestinal obstruction;
- •Drug or alcohol abuse;
- •No legal capacity or limited legal capacity;
- •Pregnant or lactating women.
结局指标
主要结局
relapse-free survival
时间窗: 3 years
The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death
次要结局
- overall survival(5 years)
- postoperative complication(After surgery during one month)
- postoperative mortality(After surgery during 90 days)
- postoperative hospital stay(30 days post operatively)
研究者
Xu jianmin
Director of the Department of Colorectal Surgery
Fudan University