A Multicenter Randomized Controlled Trial of Video-Assisted Thoracoscopic Resection Combined With Intraoperative Radiofrequency Ablation Versus Video-Assisted Thoracoscopic Resection Alone for Synchronous Multiple Primary Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline
研究概览
简要总结
This multicenter randomized controlled trial will compare two surgical approaches for patients with synchronous ipsilateral multiple primary lung cancer, meaning two or more primary lung cancers diagnosed at the same time in the same lung. The study aims to determine whether combining thoracoscopic resection with radiofrequency ablation can preserve more lung function while maintaining acceptable tumor control and safety compared with thoracoscopic resection alone.
A total of 160 participants will be randomly assigned in a 1:1 ratio to one of two groups. In the combined-treatment group, the main lung lesion will be removed by video-assisted thoracoscopic surgery, and the secondary lesion will be treated with intraoperative computed tomography-guided radiofrequency ablation. In the surgery-alone group, both the main and secondary lesions will be removed by video-assisted thoracoscopic surgery.
The primary outcome is the change in forced expiratory volume in one second (FEV1), a standard measure of lung function, from baseline to 6 months after surgery. Other outcomes include local recurrence, treatment-related complications, disease-free and overall survival, length of hospital stay, medical costs, quality of life, patient satisfaction, and the change in postoperative lung volume compared with preoperative lung volume, as quantitatively measured using three-dimensional chest computed tomography reconstruction. Participants will be followed at approximately 1, 3, 6, 12, and 24 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years, inclusive.
- •Diagnosis of synchronous ipsilateral multiple primary lung cancer based on imaging and/or biopsy findings and confirmed by a multidisciplinary team.
- •The main lesion is considered suitable for video-assisted thoracoscopic lobectomy or sublobar resection, with complete resection anticipated.
- •The secondary lesion is considered suitable for both video-assisted thoracoscopic sublobar resection and intraoperative CT-guided radiofrequency ablation.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Preoperative forced expiratory volume in 1 second of at least 50% of the predicted value.
- •Ability to understand the study requirements and willingness to provide written informed consent.
排除标准
- •Distant metastatic disease or N2 or N3 lymph node involvement.
- •Severe cardiac or pulmonary dysfunction that would preclude the planned surgery, anesthesia, or radiofrequency ablation.
- •Previous pulmonary surgery.
- •Pregnancy or breastfeeding.
- •Active bleeding disorder or severe coagulation abnormality.
- •Uncontrolled pulmonary infection or active pulmonary tuberculosis.
- •The secondary lesion cannot be safely accessed using the intraoperative CT-guided radiofrequency ablation system.
- •The secondary lesion is adjacent to a major blood vessel or another critical structure such that radiofrequency ablation is considered unsafe or unsuitable.
研究组 & 干预措施
Thoracoscopic Resection Plus Radiofrequency Ablation
Participants will undergo video-assisted thoracoscopic lobectomy or sublobar resection of the main lesion combined with intraoperative computed tomography-guided radiofrequency ablation of the secondary lesion.
干预措施: Video-Assisted Thoracoscopic Resection of the Main Lesion (Procedure)
Thoracoscopic Resection Plus Radiofrequency Ablation
Participants will undergo video-assisted thoracoscopic lobectomy or sublobar resection of the main lesion combined with intraoperative computed tomography-guided radiofrequency ablation of the secondary lesion.
干预措施: Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion (Procedure)
Thoracoscopic Resection Alone
Participants will undergo video-assisted thoracoscopic lobectomy or sublobar resection of the main lesion combined with sublobar resection of the secondary lesion, without radiofrequency ablation.
干预措施: Video-Assisted Thoracoscopic Resection of the Main Lesion (Procedure)
Thoracoscopic Resection Alone
Participants will undergo video-assisted thoracoscopic lobectomy or sublobar resection of the main lesion combined with sublobar resection of the secondary lesion, without radiofrequency ablation.
干预措施: Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion (Procedure)
结局指标
主要结局
Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline
时间窗: From baseline (preoperative assessment) to 6 months after surgery
FEV1 will be measured before surgery and at 6 months after surgery. The percentage change from baseline will be calculated as: \[(FEV1 at 6 months - preoperative FEV1) / preoperative FEV1\] × 100%. A less negative percentage change indicates better preservation of lung function.
次要结局
- Local Recurrence Rate Within 1 Year After Surgery(From surgery to 12 months after surgery)
- Incidence of CTCAE Grade 2 or Higher Postoperative Complications(From surgery through 30 days after surgery)
- 2-Year Disease-Free Survival Rate(24 months after surgery)
- 2-Year Overall Survival Rate(24 months after surgery)
- Postoperative Length of Hospital Stay(From the date of surgery through first discharge from the index hospitalization, an anticipated average of 5 days after surgery)
- Total Cost of the Index Hospitalization(From admission for the study surgery through first discharge from the index hospitalization, with finalized cost data assessed within 7 days after discharge)
- Change From Baseline in EuroQol 5-Dimension 5-Level Index Score(Baseline and 1, 3, 6, 12, and 24 months after surgery)
- Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer Scores(Baseline and 1, 3, 6, 12, and 24 months after surgery)
- Participant Satisfaction With the Assigned Treatment(6 months after surgery)
- Percentage Change in Lung Volume Measured by Three-Dimensional CT Reconstruction From Baseline(From baseline to 6 months after surgery)