NL-OMON21471尚未招募不适用
Correlation between endogenous DPD substrate concentrations and the pharmacokinetics and toxicity of 5-fluorouracil in patients with colorectal or pancreas cancer
Catharina Hospital Eindhoven0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational non invasive
入排标准
入选标准
- •1. Pathologically confirmed malignancy for which treatment with 5-FU is indicated in the FOLFOX, FOLFIRI or FOLFIRINOX regimen.
- •2. Age = 18 years
- •3. Able and willing to give written informed consent
- •4. WHO performance status 0-2
- •5. Minimal acceptable safety laboratory values defined as
- •a. ANC of = 1.5 x 109 /L
- •b. Platelet count of = 100 x 109 /L
- •c. Hepatic function as defined by serum bilirubin = 1.5 x ULN, ALAT and ASAT = 2.5 x ULN; in case of liver metastases ALAT and ASAT = 5 x ULN.
- •d. Renal function as defined by MDRD >30 mL/min
排除标准
- •1. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety
- •2. Women who are pregnant or breast feeding
- •3. Patients in whom the bolus injection will be skipped due to e.g. toxicity of previous chemo therapy regimen.
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