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.