Video-Assisted Thoracoscopic Surgery Combined With Radiofrequency Ablation Versus VATS Alone for Multiple Primary Lung Cancer

N/ANot Yet RecruitingNCT07819669

Cancer Institute and Hospital, Chinese Academy of Medical Sciences160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Multiple Primary Lung Cancers

Interventions

Video-Assisted Thoracoscopic Resection of the Main LesionPROCEDURE

The 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 LesionPROCEDURE

The 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 LesionPROCEDURE

The 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 1. * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: From baseline (preoperative assessment) to 6 months after surgery

Secondary Outcomes

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.

Time frame: From surgery to 12 months after surgery

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.

Time frame: From surgery through 30 days after surgery

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.

Time frame: 24 months after surgery

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.

Time frame: 24 months after surgery

Postoperative Length of Hospital Stay

The number of days from the date of the study surgery to discharge from the index hospitalization will be obtained from hospital records.

Time frame: 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

The total direct medical cost incurred during the index hospitalization will be obtained from hospital billing records. The total cost will include charges associated with surgery, anesthesia, hospitalization, examinations, medications, and management of postoperative complications.

Time frame: 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

Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.

Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery

Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer Scores

The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to assess symptom severity and symptom interference.

Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery

Participant Satisfaction With the Assigned Treatment

Participant satisfaction with the assigned treatment will be assessed using a prespecified 5-point Likert scale ranging from 1, very dissatisfied, to 5, very satisfied. Higher scores indicate greater treatment satisfaction.

Time frame: 6 months after surgery

Percentage Change in Lung Volume Measured by Three-Dimensional CT Reconstruction From Baseline

Lung volume will be quantitatively measured using three-dimensional reconstruction of chest computed tomography images obtained before surgery and at 6 months after surgery.

Time frame: From baseline to 6 months after surgery