Multiple Primary Lung CancersNCT07819669
Video-Assisted Thoracoscopic Surgery Combined With Radiofrequency Ablation Versus VATS Alone for Multiple Primary Lung Cancer
A study testing Video-Assisted Thoracoscopic Resection of the Main Lesion, Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion and Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion in people with Multiple Primary Lung Cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Primary Lung Cancers
- What is being tested?
- Video-Assisted Thoracoscopic Resection of the Main Lesion, Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion and Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical
Beijing, 100021
Fengwei Tan, +86-10-8778-7790, tanfengwei@126.com
Fengwei Tan
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
Baihua Zhang, +86-755-66618179, baihua1068@qq.com
Baihua Zhang
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
Xiaofei Zhuang, +86-351-4651147, xiaofei_zhuang@126.com
Xiaofei Zhuang
About this study
Official title: 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
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
- Being tested
- Video-Assisted Thoracoscopic Resection of the Main Lesion, Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion, Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion
- Keywords
- Multiple Primary Lung Cancer, Video-Assisted Thoracoscopic Surgery, Radiofrequency Ablation, Hybrid Surgery, Lung Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Thoracoscopic Resection of the Main LesionProcedure or surgery
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 or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Video-Assisted Thoracoscopic Resection of the Main Lesion; Procedure: Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (preoperative assessment) to 6 months after surgery
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Primary Lung CancersStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Fengwei Tan, MD, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819669
- Sponsor's protocol ID
- NCC5588
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07819669
- Acronym / sponsor ID
- NCC5588
- Conditions
- Multiple Primary Lung Cancers
- Keywords
- Multiple Primary Lung Cancer, Video-Assisted Thoracoscopic Surgery, Radiofrequency Ablation, Hybrid Surgery, Lung Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic Resection Plus Radiofrequency Ablation | Experimental | Procedure: Video-Assisted Thoracoscopic Resection of the Main Lesion, Procedure: Intraoperative CT-Guided Radiofrequency Ablation of the Secondary LesionParticipants 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. |
| Thoracoscopic Resection Alone | Active comparator | Procedure: Video-Assisted Thoracoscopic Resection of the Main Lesion, Procedure: Video-Assisted Thoracoscopic Sublobar Resection of the Secondary LesionParticipants will undergo video-assisted thoracoscopic lobectomy or sublobar resection of the main lesion combined with sublobar resection of the secondary lesion, without radiofrequency ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Assisted Thoracoscopic Resection of the Main LesionThe 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. | Procedure or surgery | Thoracoscopic Resection Alone, Thoracoscopic Resection Plus Radiofrequency Ablation |
| Intraoperative CT-Guided Radiofrequency Ablation of the Secondary LesionThe 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. | Procedure or surgery | Thoracoscopic Resection Plus Radiofrequency Ablation |
| Video-Assisted Thoracoscopic Sublobar Resection of the Secondary LesionThe 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. | Procedure or surgery | Thoracoscopic Resection Alone |
Primary outcome
Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline
Time frame: 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.
10 secondary outcomes
Local Recurrence Rate Within 1 Year After Surgery
Time frame: From surgery to 12 months after surgery
Incidence of CTCAE Grade 2 or Higher Postoperative Complications
Time frame: From surgery through 30 days after surgery
2-Year Disease-Free Survival Rate
Time frame: 24 months after surgery
2-Year Overall Survival Rate
Time frame: 24 months after surgery
Postoperative Length of Hospital Stay
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
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
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer Scores
Time frame: Baseline and 1, 3, 6, 12, and 24 months after surgery
Participant Satisfaction With the Assigned Treatment
Time frame: 6 months after surgery
Percentage Change in Lung Volume Measured by Three-Dimensional CT Reconstruction From Baseline
Time frame: From baseline to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fengwei Tan, MD, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Assisted Thoracoscopic Resection of the Main Lesion, Intraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion and Video-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion in people with Multiple Primary Lung Cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengwei Tan, MD, PhD (010-8778-7790, tanfengwei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline (time frame: From baseline (preoperative assessment) to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.