NCT00977119已完成不适用
Investigation of Genetic Determinants of Capecitabine Toxicity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- Genetic variants of toxicity
研究概览
简要总结
The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).
Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with breast cancer in whom single agent capecitabine therapy is being considered
- •aged 18 years and older
排除标准
- •patients who have previously received capecitabine are excluded
- •patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
- •serum albumin less than 3.0 g/dL within the last 30 days
- •creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min [/body surface area (BSA)] (within the last 30 days)
- •inability to understand and give informed consent to participate
- •patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus
- •patients with prior or concurrent pelvic irradiation
- •patients who use an ostomy for fecal excretion
- •there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician
结局指标
主要结局
Genetic variants of toxicity
时间窗: 2 years
次要结局
- Multiple genetic variants as predictors(2 years)
- Genome-wide association (potential)(2 years)
- Time to toxicity based on genetics(2 years)
- Correlative sample collection(2 years)
研究者
研究点 (13)
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