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.
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.
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.
Parallel
Video-Assisted Thoracoscopic Resection of the Main Lesion
Procedure/SurgeryThe main lesion will be treated with video-assisted thoracoscopic lobectomy or sublobar resection according to the preoperative surgical plan. This intervention will be performed in both study arms.
Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion
Procedure/SurgeryThe secondary lesion will be treated with radiofrequency ablation under intraoperative computed tomography guidance during the same operative session as video-assisted thoracoscopic resection of the main lesion. This intervention will be administered only to participants assigned to the experimental arm.
Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion
Procedure/SurgeryThe secondary lesion will be removed by video-assisted thoracoscopic sublobar resection, including segmentectomy or wedge resection as clinically appropriate, during the same operative session as resection of the main lesion. This intervention will be administered only to participants assigned to the active comparator arm.
Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline
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.
Local Recurrence Rate Within 1 Year After Surgery
The proportion of participants who experience local recurrence at a treated pulmonary lesion site within 12 months after surgery. Local recurrence will be assessed by follow-up chest imaging and determined according to protocol-defined criteria.
Incidence of CTCAE Grade 2 or Higher Postoperative Complications
The proportion of participants who experience at least one postoperative complication of Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
2-Year Disease-Free Survival Rate
Disease-free survival is defined as the time from randomization to the first documented disease recurrence or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last disease assessment. The proportion of participants remaining alive and disease-free at 24 months will be assessed.
2-Year Overall Survival Rate
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive. The proportion of participants alive at 24 months will be assessed.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator
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