Adjuvant Chemotherapy Confers Survival Benefit Only in High-Risk Pathologic Stage I Non-Squamous NSCLC: A Multicenter Prospective Cohort Study and Machine-Learning-Based Decision Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,072
- 主要终点
- 5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method.
研究概览
简要总结
Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection.
The main questions it aims to answer are:
Does ACT improve recurrence-free survival (RFS) compared with observation alone?
Does ACT provide disease-free survival (DFS) benefit in this patient population?
Researchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes.
Participants will:
Receive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines.
Be followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed non-squamous NSCLC
- •Patients must be ≥18 years of age at the time of diagnosis
- •Pathological stage I disease (T1-2N0M0) according to the AJCC 8th edition (specify if applicable)
- •Patients must have undergone complete surgical resection (R0) with systematic lymph node dissection
- •Surgery performed between January 1, 2015 and December 31, 2019
排除标准
- •Prior history of malignant tumors or presence of synchronous other primary malignancy
- •Multiple primary lung cancers diagnosed at baseline
- •Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy
- •Perioperative death occurring within 30 days after surgery
- •Incomplete or missing clinical or pathological information
- •Loss to follow-up before the first scheduled surveillance assessment
研究组 & 干预措施
Adjuvant chemotherapy
干预措施: Adjuvant chemotheapy (Drug)
结局指标
主要结局
5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method.
时间窗: Up to 5 years after surgery
DFS is defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. Patients without an event will be censored at the last follow-up. Data will be summarized using Kaplan-Meier survival analysis, with median DFS and 95% confidence intervals.
次要结局
- 5-year Recurrence-Free Survival (RFS), defined as time from surgery to the first recurrence or death from any cause, estimated by Kaplan-Meier method(Up to 5 years after surgery.)