The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 627
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.
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
- •75 years old
- •ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
- •Pathological diagnosis of colon cancer adenocarcinoma
- •At least one measurable objective tumor lesions which could be evaluated.
- •Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
- •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
- •No systemic chemotherapy
- •Patients with voluntary participation, and sign the informed consent
排除标准
- •Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
- •Multiple primary colorectal carcinoma
- •Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
- •Uncontrolled pleural effusion
- •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 or meningeal metastasis
- •Pregnancy or breast-feeding women
- •Alcohol or drug addictions
- •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
Chemotherapy plus surgery
Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
干预措施: resection of primary tumor (Procedure)
Chemotherapy plus surgery
Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
干预措施: XELOX (Drug)
Chemotherapy plus surgery
Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
干预措施: mFOLFOX6 (Drug)
Chemotherapy alone
Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
干预措施: XELOX (Drug)
Chemotherapy alone
Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Overall survival
时间窗: 5-year
次要结局
- Objective response rate(1-year)
- The proportion of surgical intervention in control group(1-year)
- The rate of adverse events resulted from chemotherapy(3-year)
- Progression-free survival 1(3-year)
- Progression-free survival 2(3-year)
- The quality of life postoperatively(3-month, 6-month, 9-month, 12-month, 18-month, 24-month)
- The rate of postoperative complications(1-year)