A Randomized Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients With Unresectable Metastatic Lesions
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment)
研究概览
简要总结
The primary endpoint is to evaluate the TFS (time to failure of strategy).
详细描述
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.
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
- •18~75 ears old
- •Pathological diagnosis of colon cancer adenocarcinoma
- •No systemic chemotherapy for metastatic tumors
- •ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- •At least one measurable objective tumor lesions
- •ANC≥1.5*109/L；PLT≥90*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
- •Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
- •Patients with voluntary participation, and sign the informed consent
排除标准
- •Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- •With uncontrollable large pleural or peritoneal effusion
- •Alcohol or drug addictions
- •Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
- •With brain metastasis
- •Multiple primary colorectal carcinoma
- •Pregnancy or breast-feeding women
- •There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation.
研究组 & 干预措施
XELOX plus surgery
Eight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated.
干预措施: resection of primary lesion (Procedure)
XELOX plus surgery
Eight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated.
干预措施: XELOX (Drug)
XELOX
Eight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
干预措施: XELOX (Drug)
结局指标
主要结局
TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment)
时间窗: the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years.
次要结局
未报告次要终点