Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Patients in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
研究概览
简要总结
The purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head & neck (1L R/M SCCHN).
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
- •Participants are included in Cohort 1 - Augment if they meet the following criteria:
- •Adults18 years or older
- •Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-
- •Prescribed 1L treatment for R/M SCCHN
- •Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants
- •Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy
- •Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees
- •Participants are included in Cohort 1 if they meet the following criteria:
- •Adults 18 years or older
- •Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-
- •Prescribed 1L treatment for R/M SCCHN
- •Treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants
- •Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy
- •Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees
排除标准
- •Participants were excluded from either cohort if they meet the following criteria:
- •Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN
- •Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).
结局指标
主要结局
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
时间窗: At Baseline
Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height
时间窗: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight
时间窗: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)
时间窗: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage
时间窗: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use
时间窗: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities
时间窗: At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive radiation within 6 months prior to early stage diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Undergo related surgeries within 6 months prior to early stage diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis
时间窗: At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping
时间窗: At Baseline
Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease
时间窗: At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease
时间窗: At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab
时间窗: At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken
时间窗: At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution
时间窗: At Baseline
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy
时间窗: At Baseline
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response
时间窗: Up to approximately 36 months
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival
时间窗: Up to approximately 36 months
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival
时间窗: Up to approximately 36 months
次要结局
- Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1(At Baseline)
- Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1(Up to approximately 36 months)