EUCTR2008-003980-38-SK进行中（未招募）不适用
An open label study of the effect of Xeloda and radiotherapy on pathological response rate in patients with locally advanced rectal cancer.
Roche Slovensko s.r.o.0 个研究点开始时间: 2008年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with histologically or cytologically confirmed diagnosis of rectal carcinoma, who are planned to have surgery for rectal cancer and are considered to have benefit from pre-operative combined chemo-radiotherapy, (stage cT3, cT4, fixative tumors, tumors primarily inoperaberable
- •- Age more than 18 and less than 80 years
- •– Outpatients, with ECOG performance status 0-2
- •– Patients willing and able to comply with the study protocol
- •– Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •–Prior radiotherapy or chemotherapy for colorectal cancer.
- •–Serious comorbidities:
- •Congestive heart failure, angina pectoris, previous history of myocardial infarction, uncontrolled hypertension or arrhythmias.
- •History of significant neurological or psychiatric disorders including dementia or seizures.
- •Serious uncontrolled active infection.
- •Other serious comorbidities that could affect patients safety during study
- •–Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- •–Pregnant or lactating women.
- •–Women of child-bearing potential unless using a reliable and appropriate contraceptive method (post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •–Sexually active males unwilling to practice contraception during the study.
- •–Life expectancy of < 3 months.
- •–Neutrophils < 2 x 109/L or platelets < 100 x 109/L.
- •–Total bilirubin > 1.5 x the upper-normal limits (UNL) of the Institutional normal values and ASAT,ALAT, GMT > 2.5 x UNL, alkaline phosphatase > 2.5 x UNL
- •–Creatinine > 150 micromol/L or creatinine clearance < 30ml/min.
- •–Significant stomach or small intestine disease.
- •–Hypersensitivity to capecitabine, some of the excipients or flurouracil.
- •–Known deficit of dihydropyrimidindehydrogenase (DPD).
- •–Treatment with sorivudine or with chemically related analogues, e.g. brivudine
研究者
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