Perioperative Treatment Patterns and Clinical Outcomes in Early-Stage Non-Small Cell Lung Cancer: a Real-World Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- event-free survival
研究概览
简要总结
This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. According to the inclusion and exclusion criteria, perioperative NSCLC patients admitted to the study center from January 1, 2020, to one year after the study initiation will be retrospectively screened and collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage I-III NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
- •Patients who have undergone radical lung cancer surgery.
- •Patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined.
排除标准
- •Patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment.
- •Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
- •Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- •Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
结局指标
主要结局
event-free survival
时间窗: From date of diagnosis until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 36 months
the time from randomization to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause;
overall survival
时间窗: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
from diagnosis to death
次要结局
- R0 resection rate(usually 1 week after surgery)
- major pathological response(usually 1 week after surgery)
- p-CR(usually 1 week after surgery)
研究者
Hua Zhong
professor
Shanghai Chest Hospital