Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 591
- 主要终点
- Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN
研究概览
简要总结
The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patient (18 years old or older) with a confirmed diagnosis or R/M head and neck, may be living or deceased at time of enrollment in the study
- •Diagnosis of R/M head and neck cancer between 01July2013 and 30June2014 (study index period)
排除标准
- •If female patient, pregnant or lactating between 01July2013 and 30June2014
- •Enrolled in cancer treatment-clinical trials since diagnosis of R/M head and neck cancer during the study index period
结局指标
主要结局
Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN
时间窗: approximately 12 months
Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN
时间窗: approximately 12 months
Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen
时间窗: approximately 12 months
Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN
时间窗: approximately 12 months
Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN
时间窗: approximately 12 months
次要结局
- Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics(approximately 12 months)
- Frequency of R/M SCCHN-related health care resource use(approximately 12 months)
- Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics(approximately 12 months)