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

NCT07819669 | Not Yet Recruiting DMC

• 1 other identifier: NCC5588
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Multiple Primary Lung Cancers

Keywords

Multiple Primary Lung Cancer; Video-Assisted Thoracoscopic Surgery; Radiofrequency Ablation; Hybrid Surgery; Lung Function

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (preoperative assessment) to 6 months after surgery

Secondary Outcomes (10)

• 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

Study Arms (2)

Thoracoscopic Resection Plus Radiofrequency Ablation

EXPERIMENTAL

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.

Procedure: Video-Assisted Thoracoscopic Resection of the Main Lesion; Procedure: Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion

Thoracoscopic Resection Alone

ACTIVE COMPARATOR

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.

Procedure: Video-Assisted Thoracoscopic Resection of the Main Lesion; Procedure: Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion

Interventions

Video-Assisted Thoracoscopic Resection of the Main Lesion PROCEDURE

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.

Thoracoscopic Resection Alone; Thoracoscopic Resection Plus Radiofrequency Ablation

Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion PROCEDURE

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.

Thoracoscopic Resection Alone

Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion PROCEDURE

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.

Thoracoscopic Resection Plus Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (3)

Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University

Taiyuan, Shanxi, 030013, China

Location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical

Beijing, 100021, China

Location

National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Shenzhen, 518116, China

Location

Study Officials

• Fengwei Tan, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengwei Tan, MD, PhD

CONTACT

010-8778-7790; tanfengwei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)