Maintenance Tegafur-uracil Versus Observation Following Adjuvant Oxaliplatin-based Regimen in Patients With Stage III Colon Cancer After Radical Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Primary Objective:
To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection.
Secondary Objectives:
- To assess 5-year overall survival (OS) in each arm
- To assess the safety profiles
详细描述
Objectives:
- Primary Objective:
To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection. 2. Secondary Objectives:
- To assess 5-year overall survival (OS) in each arm
- To assess the safety profiles
Patient Selection and Enrollment:
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion, each subject must fulfill all of the following criteria:
- •pathologically confirmed colon carcinoma;
- •stage III disease (T1-4, N1-2, M0 as defined by AJCC 7th Edi.);
- •completion of adjuvant oxaliplatin-based regimen without evidence of any recurrent disease;
- •entry of the trial within 3 weeks after adjuvant oxaliplatin-based regimen;
- •performance status of ECOG 0, 1, 2;
- •age between 20 and 80 years old;
- •written informed consent to participate in the trial.
排除标准
- •Patients who fulfill any of the following criteria will be excluded from the trial:
- •previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;
- •inadequate hematopoietic function defined as below:
- •hemoglobin < 9 g/dL;
- •absolute neutrophil count (ANC) < 1,500/mm3;
- •platelet count < 100,000/mm3;
- •inadequate organ functions defined as below:
- •total bilirubin > 2 times upper limit of normal (ULN);
- •hepatic transaminases (ALT and AST) > 2.5 x ULN;
- •creatinine > 1.5 x ULN;
- •other significant medical conditions that are contraindicated to tegafur-uracil or render patient at high risk from treatment complications based on investigator's discretion;
- •presence of other serious concomitant illness;
- •participation in another clinical trial with any investigational drug within 30 days prior to entry;
- •pregnant or lactating women or women of childbearing potential.
研究组 & 干预措施
maintenance therapy
Patients will receive oral tegafur-uracil 400mg/day (100mg/Cap., 2 capsules each time, twice a day), combined with oral folinic acid 30mg/day (15mg/Tab., 1 tablet each time, twice a day), and continue for one year.
干预措施: tegafur-uracil (Drug)
observation arm
Patients will be observed following adjuvant oxaliplatin-based regimen.
干预措施: tegafur-uracil (Drug)
结局指标
主要结局
Disease free survival
时间窗: three to six months
次要结局
未报告次要终点