A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis
试验速览
- 阶段
- 3 期
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- disease free survival rate
研究概览
简要总结
This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
详细描述
Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.
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
- None
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
- •Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. )
- •Liver metastasis should be resected with R0 resection and to save enough normal liver tissue
- •Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50%
- •No metastasis of other organs or lymph nodes in abdominal cavity
- •No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months
- •Age 18 to 75 years old
- •Karnofsky performance status ≥70
- •Life expectancy of ≥3 month
- •Bilirubin level < 1.5mg/dL
- •Serum creatinine <1.0 times ULN
- •Absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
- •Having signed informed consent
排除标准
- •previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months.
- •No R0 resection or not enough normal liver tissue left
- •previous radiotherapy of target lesions
- •accompanied with unresectable other metastasis or malignant pleural fluids or ascites.
- •complete or uncompleted liver obstruction
- •peripheral neuropathy(NCI-CTC grade 1 or more)
- •mental disturbance neuropathy that influence the cognition, including brain metastasis
- •other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months
- •Other previous malignancy within 5 year, except non-melanoma skin cancer
- •accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials.
- •Pregnancy or lactation period
研究组 & 干预措施
1
2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
干预措施: neoadjuvant chemotherapy with oxaliplatin and capecitabine (Drug)
1
2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis
干预措施: resection of liver metastasis (Procedure)
2
no neoadjuvant chemotherapy, resect the liver metastasis directly
干预措施: resection of liver metastasis (Procedure)
结局指标
主要结局
disease free survival rate
时间窗: 3 year
次要结局
- R0 resection rate(at the time of pathological report)
- survival rate and over survival(5 year)
- surgery related mortality(peri-operation period)
- response rate and safety of XELOX as a neoadjuvant regimen(no time frame)