JPRN-jRCTs031180378已完成2 期
Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer - CROWN study
Goto Koichi0 个研究点目标入组 25 人开始时间: 2019年3月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
The study was conducted to evaluate efficacy and safety of a double combination of oral granisetron plus dexamethasone. Target sample size 30, but the study stopped at 25 patients enrollment due to slow accrual. Twenty of 25 patients achieved CR and the CR rate was 80% (90% confidence interval; 40%-65%), which met the primary endpoint. The oral granisetron plus dexamethasone is an effective prophylactic treatment for crizotinib induced nausea and vomiting.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. histologically or cytologically confirmed NSCLC
- •2. diagnosed with ALK or ROS1 fusion gene
- •3. planned to treat with Crizotinib within 2 weeks
- •4. 20years old or older
- •5. possible to oral intake
- •6. ECOG PS 0-2
- •7. adequate organ function
- •8. Written informed consent
排除标准
- •1. medical history of severe allergy
- •2. symptomatic brain metastasis
- •3. medical history of seizure and who need epilepsy drug
- •4. gastrointestinal obstruction
- •5. pregnant, breast-feeding, and childbearing potential
- •6. diagnosed with interstitial lung disease or pulmonary fibrosis by chest CT
- •7. difficult to registration due to mental illness
- •8. systemic steroid administration (oral or intravenous)
- •9. started to treat with opioid for pain control within 7days before registration
- •10. vomiting and/or more than Gr2 nausea (CTCAE) within 72 hours after registration
- •11. impossible to record medical diary
- •12. no prior Crizotinib
- •13. assessed unsuitable to this study by attending doctor because of any other reason
研究者
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