NCT00594529Unknown2 期
Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Curative resection rates of liver metastases
研究概览
简要总结
The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
- •Liver lesions are measurable by spiral CT or SPIO-MRI scans.
- •Extrahepatic lesions include lung metastases which can be resected curatively.
- •Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
- •No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
- •No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
- •Performance status (ECOG): 0-1
- •Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
排除标准
- •Excluded are cases with conditions as below:
- •Peritoneal or pleural fluid retention to be drained.
- •Multiple malignancies to be treated.
- •Peripheral neural disturbances.
- •Active infectious diseases.
- •Severe watery diarrhea.
- •Mental disturbances.
- •Treatment history of continuous, oral or intravenous steroid therapy.
- •Previous history of ischemic heart diseases.
- •Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
- •Previous history of severe drug-induced allergy.
结局指标
主要结局
Curative resection rates of liver metastases
时间窗: 2 years after the operations
次要结局
- Completion rates of neoadjuvant chemotherapy(2 years after the operation)
研究者
研究点 (2)
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