NCT00891332已完成2 期
Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 6
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proved adenocarcinoma
- •Unresectable and recurrent colorectal cancer
- •Age20 ≤ at enrollment
- •Performance status 0 or 1 (ECOG)
- •No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
- •Adequate hematologic, hepatic and renal functions
- •At least one measurable lesion by RECIST criteria
排除标准
- •Serious drug hypersensitivity
- •Pregnant or nursing
- •Bleeding from gastrointestinal tract
- •Simultaneously active double cancer
- •Serious illness or medical condition
- •Brain metastasis
研究组 & 干预措施
1
Experimental
S-1 plus LV
干预措施: S-1 plus LV (The combination therapy of S-1 and Leucovorin) (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: During chemotherapy
次要结局
- Safety(During chemotherapy)
- Progression free survival (PFS)(Until progression)
- Disease control rate(DCR)(During chemotherapy)
- Time to treatment failure (TTF)(Until progression)
- Overall survival (OS)(Over two years from registration)
- Feasibility(During chemotherapy)
- Pharmacokinetics(During chemotherapy)
研究者
研究点 (6)
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