Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 9
- 主要终点
- Validate the utility of an IgE anti-cetuximab test in the treatment strategy
研究概览
简要总结
The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.
研究设计
- 研究类型
- Observational
- 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
- •Patient informed consent,
- •Patient aged over 18 years
- •Patients with a WHO performance status ≤ 2,
- •Colon cancer or upper aero-digestive tract cytologically or histologically proven
- •Patients with an indication to the theoretical use of cetuximab for colon neoplasia or upper aero-digestive tract,
- •Haematological and biochemical compatible with combination therapy with cetuximab.
排除标准
- •Patients previously treated with cetuximab,
- •A person deprived of liberty or under supervision.
结局指标
主要结局
Validate the utility of an IgE anti-cetuximab test in the treatment strategy
时间窗: 3 years
We hypothesize that a positive specific IgE assay predicts the occurrence of an allergic reaction during the first dose of cetuximab. Thus, in population areas where the prevalence of specific IgE positive plasma is higher, the use of alternative therapies in patients with a positive test would reduce the incidence of anaphylactic reactions to cetuximab. If the use of specific IgE anti-cetuximab in the treatment strategy is effective, there will be reduction in the incidence of anaphylaxis to cetuximab in the participating centers.
次要结局
未报告次要终点