NCT00997685Unknown2 期
A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
研究概览
简要总结
This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.
详细描述
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 and 65
- •Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
- •Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
- •No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
- •Patients with adequate hepative, renal and bone marrow function
- •Signed written informed consent
排除标准
- •Pregnant or nursing patients (fertile patients must use effective contraception)
- •Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Preexisting grade 2 or greater peripheral neuropathy
- •Concurrent uncontrolled illness
- •Ongoing or active infection
- •Psychiatric illness or social situation that would preclude study compliance
- •Less than 6 months since prior adjuvant fluorouracil-based chemotherapy
- •Prior chemotherapy for liver metastasis
- •Prior oxaliplatin for colorectal cancer
- •Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
- •Prior or concurrent radiotherapy for metastatic disease
- •Prior or concurrent radiofrequency ablation for metastatic disease
- •concurrent treatment with any other anti-cancer therapy.
研究组 & 干预措施
Capecitabine plus oxaliplatin，mCRC
Experimental
干预措施: Capecitabine plus oxaliplatin (Drug)
结局指标
主要结局
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
时间窗: 3.6 years
次要结局
- To evaluate the safety profile of XELOX peri-operative treatment(3.6 years)
- To evaluate the R0 resection rate(3.6 years)
- To investigate the response rate(3.6 years)
研究者
研究点 (1)
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