Multiple Primary Lung Cancers
Conditions
Keywords
Multiple Primary Lung Cancer, Video-Assisted Thoracoscopic Surgery, Radiofrequency Ablation, Hybrid Surgery, Lung Function
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.
Interventions
PROCEDUREVideo-Assisted Thoracoscopic Resection of the Main Lesion
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.
PROCEDUREIntraoperative CT-Guided Radiofrequency Ablation of the Secondary Lesion
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.
PROCEDUREVideo-Assisted Thoracoscopic Sublobar Resection of the Secondary Lesion
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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Recurrence Rate Within 1 Year After Surgery | From surgery to 12 months 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 | From surgery through 30 days after surgery | 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 | 24 months after surgery | 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 | 24 months after surgery | 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. |
| 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 | The number of days from the date of the study surgery to discharge from the index hospitalization will be obtained from hospital records. |
| 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 | 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. |
| Change From Baseline in EuroQol 5-Dimension 5-Level Index Score | Baseline and 1, 3, 6, 12, and 24 months after surgery | Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. |
| Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer Scores | Baseline and 1, 3, 6, 12, and 24 months after surgery | The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to assess symptom severity and symptom interference. |
| Participant Satisfaction With the Assigned Treatment | 6 months after surgery | 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. |
| Percentage Change in Lung Volume Measured by Three-Dimensional CT Reconstruction From Baseline | From baseline to 6 months after surgery | Lung volume will be quantitatively measured using three-dimensional reconstruction of chest computed tomography images obtained before surgery and at 6 months after surgery. |
Countries
China
Contacts
CONTACTFengwei Tan, MD, PhD
PRINCIPAL_INVESTIGATORFengwei Tan, MD, PhD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed