A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 25
- 主要终点
- Number of Patients with Serious Adverse Reactions
研究概览
简要总结
This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label.
详细描述
This is a prospective, non-randomized, observational, single arm, cohort study, wherein 200 patients of unresectable LA SCCHN will be enrolled. The eligibility of the patients will be decided by the Investigators based on the locally approved label. The patients will be treated with Cetuximab in combination with RT for a duration of 8 weeks and then followed up for 3 years. The objectives of this study are to record safety and efficacy information on the treatment combination in the general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria as per the product label for LA SCCHN approved by India Health Authority
- •Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- •Patient willing and able to give written Informed Consent
- •Patient capable of complying with study data collection procedures
排除标准
- •Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority
结局指标
主要结局
Number of Patients with Serious Adverse Reactions
时间窗: 3 years
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
次要结局
- Response Rate(8 weeks (Post completion of treatment duration))
- Progression Free Survival(3 years)
- Overall Survival(3 years)
- Duration of Locoregional Disease Control(3 years)
- Management of skin conditions due to treatment protocol(3 years)