NL-OMON52496招募中不适用
A combination of pre-screening for DPD deficiency by genotyping/phenotyping methods and pharmacokinetics-guided dosing of 5-FU for precision treatment to prevent severe toxicity in gastrointestinal cancer patients. - DPD guided 5FU precision treatment in GI cancer
Isala Klinieken0 个研究点目标入组 75 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •age 18 years and older
- •histological proof of gastro-intestinal cancer
- •patient is considered for treatment with capecitabine or 5-FU
- •acceptable safety laboratory values
- •ECOG performance status 0-2
- •able and willing to give written informed consent
- •able and willing to undergo blood sampling for DPYD genotyping, DPD
- •phenotyping and pharmacokinetic analysis
排除标准
- •symptomatic or uncontrolled central nervous system metastases
- •patient who cannot submit itself to the formal follow-up for psychological,
- •social, family or geographical reasons
- •women who are pregnant or breast-feeding
- •women not consenting to use adequate contraceptive precautions during the
- •significant serious pathology or any instable medical condition (cardiac
- •pathology uncontrolled, myocardial infarction within 6 months before enrolment,
- •systemic active uncontrolled infection, cirrhosis (Child-Pugh score C), renal
- •failure (GFR < 20 ml/min))
- •any investigational agent within 4 weeks before enrolment
- •cimetidine or sorivudine use (due to drug-drug interactions with
- •5-fluorouracil and capecitabine)
研究者
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