A Study to Evaluate the Efficacy of Anti-emetic Drug Aprepitant Upon the Combination Chemotherapy of Nedaplatin and Docetaxel for Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).
详细描述
The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.
- •ECOG performance status 0-
- •Aged 20-79 years old.
- •Laboratory values as follows 4000/mm3 < WBC < 12000/mm3, neutrophil count > 2000/mm3, platelet count > 100000/mm3, hemoglobin > 9.5g/dL, asparate transaminase < 2.5 X cutoff value, alanine transaminase < 2.5 X cutoff value, total bilirubin < 1.5g/dL, Serum creatinine < cutoff value, PaO2 > 60 Torr.
- •Able and willing to give valid written informed consent.
排除标准
- •Allergy against polysorbert 80 or platinum-containing drugs.
- •Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency).
- •Active and uncontrolled infectious disease.
- •Massive pleural or pericardial effusion.
- •Other malignancy requiring treatment.
- •Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential)
- •Peripheral nerve disorder.
- •Pregnant or lactating women.
- •Concurrent administration of pimozide.
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting
时间窗: Fifteen days after beginning of each cycle of chemotherapy
次要结局
- Influence on clinical outcome: Survival(Participants will be followed for 3 years after the last treatment)