A Multicountry, Multicentre, Non-interventional, Retrospective Study toDetermine the Real-world Treatment Patterns and Associated Outcomes inPatients With Resectable Early-stage (IA to IIIB) Non-small Cell LungCancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- o Surgery only
研究概览
简要总结
To describe the treatment patterns and determine their associated 3-year survival outcome according to clinical and pathologic staging in patients with resectable early-stage (IA to IIIB) (as per American Joint Committee on Cancer [AJCC] seventh edition) NSCLC
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult female and male patients aged ≥18 years or adults according to age of majority as defined by the local regulations on index date
- •Patient or next of kin/legal representative (for deceased patients at study entry unless a waiver is granted) willing and able to provide written or electronic informed consent according to the local regulations, where applicable
- •Patients diagnosed with primary stage IA to IIIB NSCLC as per seventh edition AJCC whose tumour was deemed resectable between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020 as per the medical records with availability of at least 12 months of follow-up data from the index date (date of diagnosis of early-stage [IA to stage IIIB] resectable NSCLC) unless patient died within 12 months of diagnosis.
排除标准
- •1.Patients with a concomitant cancer at the time of diagnosis of NSCLC, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
- •Patients diagnosed with stage IV NSCLC
- •Histology of the tumour is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
结局指标
主要结局
o Surgery only
时间窗: one-time
1. Proportion of patients overall and as per clinical and pathologic staging (seventh edition of the tumour nodes metastases [TNM] classification for lung cancer [AJCC]) who underwent either of the following treatment modalities:
时间窗: one-time
o Neo-adjuvant and adjuvant therapies
时间窗: one-time
2. Duration of treatment for each treatment regimen in neo-adjuvant and adjuvant treatment settings, dose of each agent, and reason(s) for stopping treatment in each setting
时间窗: one-time
3. 3-year survival rate (overall, and as per clinical and pathologic staging) defined as percentage of patients confirmed to be alive at 3 years from the index date.
时间窗: one-time
o Adjuvant therapy (chemo+/-radiotherapy) only
时间窗: one-time
o Neo-adjuvant therapy (chemo+/-radiotherapy) only
时间窗: one-time
次要结局
- Demographic and clinical-pathological characteristics (overall and as per treatment modalities)(Survival outcomes)