Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients：A Prospective, Single-arm, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Remission rate of EGFR inhibitor-related acneiform eruption
研究概览
简要总结
This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.
详细描述
The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, which affect patients' quality of life and can lead to treatment discontinuation and cetuximab dose reduction.
This prospective, single-arm, phase II clinical trial aims to explore the efficacy and safety of crisaborole ointment in Cetuximab-Related Skin Toxicity. A total of 33 mCRC patients with acneiform eruption will be enrolled. All of the participants will receive crisaborole ointment twice daily. The total follow-up time is 12 weeks.
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
- •Diagnosed mCRC and undergoing Cetuximab treatment;
- •≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
- •Age 18 years and older；
- •ECOG performance status 0-2.；
- •Bone marrow ,brain, heart, kidney and other organ function well;；
- •Expected survival time more than 3 months;
排除标准
- •The presence of any active skin disease；
- •Undergoing any current hormone therapy for any other disease;
- •Prior allergic reaction or severe intolerance to crisaborole ointment
研究组 & 干预措施
Intervention group
crisaborole ointment
干预措施: Crisaborole Ointment (Drug)
Intervention group
crisaborole ointment
干预措施: Cetuximab (Drug)
结局指标
主要结局
Remission rate of EGFR inhibitor-related acneiform eruption
时间窗: From date of randomization until the date of remission，assessed up to 8 weeks.
Grading of acneiform eruption would be assessed according to National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) 5.0. Remission was defined as a reduction in acneiform eruption from grade 2 to grade 1 or grade 3 to grade 2 sustained for at least 2 weeks.
次要结局
- Remission time of EGFR inhibitor-related acneiform eruption(From date of randomization until the date of remission，assessed up to 8 weeks.)
- Cetuximab dose reduction rate(8 weeks from randomization.)
- Cetuximab treatment discontinuation rate(8 weeks from randomization.)
- Level of paronychia, xeroderma and pruritus(8 weeks from randomization.)
- Quality of life (FACT-EGFRI-18)(The 0,2,4,6,8,10,12 weeks from randomization.)
- Quality of life（EORTC QLQ-C30)(The 0,2,4,6,8,10,12 weeks from randomization.)
研究者
WeiWei Xiao
Chief physician
Sun Yat-sen University