NCT00905047已完成3 期
Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 13
- 主要终点
- patients preference after randomization and cross-over
研究概览
简要总结
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.
Another objective of the trial is to assess and compare the safety of each treatment.
详细描述
Further study details as provided by Centre Oscar Lambret.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic colo-rectal cancer
- •Age > or = 18 years old
- •PS-WHO < or = 2
- •Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3
- •Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN
- •Effective contraception
- •Written informed consent signed
排除标准
- •Concomitant radiotherapy
- •Contraindication to fluoropyrimidines
- •Treatment with sorivudine and its chemical analogs such as brivudine
- •Severe hepatic insufficiency
- •Severe renal insufficiency
- •Pregnant or lactating woman
- •Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
研究组 & 干预措施
UFT
Other
干预措施: TEGAFUR URACIL - FOLINIC ACID (Drug)
XELODA
Other
干预措施: XELODA (Drug)
结局指标
主要结局
patients preference after randomization and cross-over
时间窗: after 2 cycles of treatment
次要结局
- safety of each treatment(at day 56 (after two cycles of treatment))
研究者
研究点 (13)
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