A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.
详细描述
This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically verified colorectal cancer
- •clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
- •age: 18-70 years
- •adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
- •no prior cancer and/or chemotherapy
- •signed informed consent
排除标准
- •patients with a history of prior malignancy
- •pregnant or lactating patients
- •known or suspected brain metastasis
研究组 & 干预措施
single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
干预措施: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 (Drug)
结局指标
主要结局
3-year disease-free survival
时间窗: 5 years
次要结局
- Number of participants with adverse events that are related to treatment(2 years)
- objective response rate(2 years)
- overall survival(6 years)
- Number of participants with surgery complications(2 years)
- Surgical complete resection rate (R0)(2 years)
研究者
Jing Huang
MD PhD
Chinese Academy of Medical Sciences