NCT01382407已完成不适用
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Relationship between acne and skin rash
研究概览
简要总结
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.
详细描述
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 above 18 years.
- •Histology or cytology proven KRAS-WT mCRC.
- •Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification)
- •Life expectancy of more than 12 weeks.
- •Written informed consent.
- •In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.
排除标准
- •Past systemic immune therapy for disease other than cancer.
- •Past immune or other target therapy for cancer (not including bevacizumab).
- •Presence of acne or acneiform rash prior to starting treatment with cetuximab.
- •Patients with treatment plan of cetuximab and capecitabine combination.
- •For female patients: the patient is pregnant or lactating.
研究组 & 干预措施
Cetuximab
All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Relationship between acne and skin rash
时间窗: Within Erbitux treatment period (upto 12 months)
To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?
次要结局
未报告次要终点
研究者
研究点 (2)
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