TCTR20210506001已完成2 期
An open-label randomized controlled trial to evaluate the efficacy of antihistamine premedication and infusion prolongation in prevention of hypersensitivity reaction to oxaliplatin.
Division of Medical Oncology, Faculty of Medicine, Chulalongkorn University0 个研究点目标入组 150 人开始时间: 2021年5月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
Of total 160 patients, HSRs occurred in one (1.3%) and ten (12.5%) patients in intervention and control groups, respectively, p 0.005. The relative risk (RR) was 0.10 (95% CI 0.013-0.763, p 0.026). Among 150 patients receiving complete treatment protocol, HSRs occurred in one (1.3%) and ten (13.2%) patients in intervention and control groups, respectively, p 0.005). One HSR in intervention group was grade I severity while there were four grade I and six grade II HSRs in control group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Eligible patients were 18 years of age or older, diagnosed with gastrointestinal cancer and receiving oxaliplatin based chemotherapy including FOLFOX (Fluorouracil, Leucovorin and Oxaliplatin), FOLFIRINOX (Fluouracil, Leucovorin, Irinotecan and Oxaliplatin) or CAPOX (capecitabine and Oxaliplatin). All patients had completed 6 cycles of FOLFOX/FOLFIRINOX or 4 cycles of CAPOX , and plan to receive 6 or 4 more cycles of FOLFOX/FOLFIRINOX or CAPOX , respectively. Patients were in Eastern Cooperative Oncology Group performance-status score of 0 or 2 and had adequate organ function.
排除标准
- •The patients with history of oxaliplatin hypersensitivity and currently receiving antihistamine were excluded. Written informed consent was obtained from all patients.
研究者
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