NCT01566942Unknown3 期
FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- disease-free survival（DFS）
研究概览
简要总结
the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.
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 adenocarcinoma in colorectal cancer
- •clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
- •no cancer cells were found in ascites
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
- •male or female, between 18 and 75 years old
- •adequate hematologic, hepatic and renal functions
- •without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled
- •not enrolled into others clinical trial during this study
- •all patients should sign the informed consent
排除标准
- •can not be tolerated operation
- •receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
- •can not be tolerated the adverse effect of drugs in these regimens
- •major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
- •metastatic disease more than one organ
- •pregnant or lactating women
研究组 & 干预措施
FOLFOX
Active Comparator
In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
干预措施: Oxaliplatin (Drug)
FOLFIRI
Experimental
in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles
干预措施: Irinotecan (Drug)
结局指标
主要结局
disease-free survival（DFS）
时间窗: 3-year disease-free survival rate
The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.
次要结局
- overall survival(OS)(5-year survival)
研究者
Yulong He
GI Surgery, the First Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University
研究点 (1)
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