NCT00721916已完成2 期
Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated 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
- 107
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proved adenocarcinoma (colorectal cancer).
- •Age: 20 ≤ at enrollment.
- •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 or Oxaliplatin containing treatment shall be excluded.
- •At least one measurable lesion by RECIST criteria
排除标准
- •Serious drug hypersensitivity.
- •Prior history of peripheral neuropathy.
- •Diarrhea .
- •Simultaneously active double cancer.
研究组 & 干预措施
1
Experimental
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
干预措施: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) (Drug)
2
Active Comparator
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
干预措施: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Until progression
次要结局
- Safety(During chemotherapy)
研究者
研究点 (1)
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