ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)

Study Overview
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Brief Summary
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This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of this study is to determine video-assisted thoracoscopic surgery is non-inferior to thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.

Detailed Description
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It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS). Secondary objectives are to compare VATS and thoracotomy for overall survival (OS), perioperative complications, pain levels and quality of life. Although there are numerous retrospective studies have indicated feasibility and effectiveness of VATS, no data has been reported from those prospective and randomized clinical trials with prognostic indicators as the primary objective. Whether VATS is non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography (CT). To determine the clinical stage, CT scans will be performed routinely and PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy or sublobar resection, history of other malignant tumors within 5 years, history of thoracic surgery or unsuitable for VATS and previous radiation or chemotherapy. In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A sample size of at least 1086 participants is required for performance equal to 80%, α-level equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be randomly assigned to either group using a random table. Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the reason will be recorded, and the cause will still be analyzed in an intention-to-treat analysis. Patients will be follow-up every 6 months to 3 years after surgery.

Official Title
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Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Procedure: VATS
* Procedure: Thoracotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical stage T1N0M0 and surgical resectable. Solid appearance on computed tomography scan. Age 18 to 75 year. Signed the informed consent form. Exclusion Criteria: Not NSCLC in pathological analysis. Not lobectomy or sublobar resection. History of other malignant tumors within 5 years. History of thoracic surgery or unsuitable for VATS. Previous radiation or chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VATS<br>Video-assisted thoracoscopic surgery | Procedure: VATS<br>* Standard video assisted thoracic surgery, no use of rib-spreader.<br>|
| Active Comparator: Thoracotomy<br>Open surgery | Procedure: Thoracotomy<br>* Standard thoracotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival means the period after surgery when no disease can be detected. | 3 years after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause. | 3 years after the surgery | 
| Rate of patients with perioperative complication | The perioperative complication includes wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc within a month after surgery. | 1 month after surgery | 
| Pain degree and quality of life | Numerical rating score (NRS) | 1 years after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video-Assisted Thoracic Surgery, Thoracotomy, Early-stage NSCLC