Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 764
- 试验地点
- 1
- 主要终点
- Distribution of Patient Clinical Characteristics in patients with ED-SCLC
研究概览
简要总结
Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.
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
- •Cohort 1 and 2:
- •Patients 18 years of age or older at SCLC diagnosis
- •Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- •Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- •Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- •Signed informed consent (where required as per local requirements)
- •Patients 18 years of age or older at SCLC diagnosis
- •Confirmed diagnosis of SCLC not earlier than October 2013
- •Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- •Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- •Signed informed consent (where required as per local requirements)
排除标准
- •Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
- •Other Inclusion/Exclusion criteria may apply
结局指标
主要结局
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
时间窗: At baseline
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Distribution of treatment patterns in patients with LD-SCLC
时间窗: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
时间窗: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
时间窗: At baseline
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
时间窗: At baseline
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
Distribution of Patient Demographic Characteristics
时间窗: At baseline
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
Distribution of treatment patterns in patients with ED-SCLC
时间窗: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
次要结局
- Progression-free survival (PFS)(Approximately 44 months)
- Objective response rate (ORR)(Approximately 44 months)
- Incidence of surgery as cancer-directed therapy(Approximately 44 months)
- Incidence of best supportive care (BSC)(Approximately 44 months)
- Incidence of palliative care(Approximately 44 months)
- Composite of SCLC-related healthcare resource utilization (HCRU)(Approximately 44 months)
- Incidence of radiation therapy as cancer-directed therapy(Approximately 44 months)
- Overall survival (OS)(Approximately 44 months)
- Mortality rate(Approximately 44 months)
- Treatment-related adverse events (AEs) leading to discontinuation(Approximately 44 months)