Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- two-year disease free survival (DFS)
研究概览
简要总结
This is a Phase II study of combined surgical resection for patients with both intra- and extra-hepatic metastases from colorectal cancer. The primary objective is to determine the two-year disease free survival (DFS) of patients who undergo surgical resection of both intra- and extra-hepatic metastases from colorectal cancer. The secondary objectives are to determine the overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, and hospital length of stay.
详细描述
This phase II clinical study will examine the outcomes of surgical therapy for patients with both intra- and extra-hepatic CRC metastases.
The treatment protocol includes surgical resection of metastases from Colorectal cancer. Multi-modality co-interventions such as chemotherapy (neo-adjuvant, or post-operative), radiofrequency ablation (RFA) and/or portal vein embolization (PVE) will be permitted.
The eligibility criteria include: patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer, the number of extra-hepatic metastases must be three or less on pre-operative imaging, all metastatic deposits must be resectable with R0 intent, there must be no contra-indications to major surgery and an ECOG performance status of 0, 1 or 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer
- •Number of extra-hepatic metastases must be 3 or less on pre-operative imaging
- •All metastatic deposits must be resectable with clear margins
- •No contra-indications to major surgery
- •ECOG performance of 0, 1 or 2
- •Age 18 or older
- •Pregnant women or women of childbearing potential are eligible if they agree to use 2 methods of effective contraception during treatment protocol
- •Written informed consent can be obtained
排除标准
- •Colorectal primary in situ
- •Four or more extra-hepatic lesions on pre-operative imaging
- •Significant medical or psychiatric conditions that preclude major surgery or may interfere with patient compliance
- •Patients receiving investigational drugs with unknown surgical risks
- •Failure to meet inclusion criteria
结局指标
主要结局
two-year disease free survival (DFS)
时间窗: 2 years
次要结局
- Overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, hospital length of stay(5 years)