Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- treatment success rate
研究概览
简要总结
To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. This phase II study was conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with imatinib-associated severe skin rash.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older, at the time of acquisition of informed consent
- •Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
- •Patients with metastatic and/or advanced (unresectable or recurrent) GISTs, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations
- •imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2
排除标准
- 未提供
研究组 & 干预措施
prednisone
prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -> 10mg/day->7.5mg/day->5mg/day->stop
干预措施: Prednisone (Drug)
结局指标
主要结局
treatment success rate
时间窗: 2 years
Treatment success was defined as maintaining imatinib without persistence or recurrence of skin rash requiring 1) additional systemic steroid treatment, and 2) interruption or dose reduction of imatinib.
次要结局
未报告次要终点
研究者
Yoon-Koo Kang
Professor
Asan Medical Center