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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
108TiP - A multi-center, prospective, randomized controlled clinical trial: Comparison between wedge resection and segmentectomy in the surgical treatment of ground glass opacity-dominant stage IA non-small cell lung cancer (ID 507)
12:30 - 13:00 | Author(s): H. Liao
Sublobectomy is an optimal choice for selected early-stage non-small cell lung cancer (NSCLC) patients. However, the criteria for the choice of two different types of sublobectomy methods (wedge resection and segmentectomy) is not clear yet. It was reported that tumor size and the percentage of the ground glass opacity (GGO) were the key parameters for the choice of the surgeries. The study was designed to verify the presumption that for GGO-dominant early stage NSCLC patients (cT1a-T1bN0M0, and GGO component ≥75%), wedge resection is equal to segmentetomy in long term survival.
The trial is a multi-center, prospective randomized, open-labelled, active-control, non-inferiority study. In the study, the cT1a-T1bN0M0 NSCLC patients with GGO component ≥75% who intended to have surgeries were enrolled. Patients were randomized into wedge resection + hilum and mediastinal lymph nodes dissection or sampling group (experimental group) and segmentectomy + hilum and mediastinal lymph nodes dissection or sampling group (control group). The primary endpoint was 5-year disease-free survival (DFS) rate. The secondary endpoints consist of 3-year DFS rate, 5/10-year overall survival rate (OSR), rates of morbidity and 30-day mortality rates, and lung function change. All the study data were descriptively analyzed. Comparison for the differences in DFS was performed by the Log-rank test. The CMHX tests were completed to compare the differences in 3-year DFS and 5/10-year OSR after taking the center effects into considerations. The differences in effectiveness were compared accordingly. In the case that statistical significance was confirmed between the groups, the non-inferiority comparisons would be completed afterwards. The impact factors of effectiveness were measured by the or the Cox modeling, or the Logistic regression analysis. The safety was measured by (serious) adverse events with a Chi-square test. To summarize, the purposes of the study are to seek for a reliable criteria of selection of different type of sublobectomy for early stage NSCLC.
Clinical trial identification:
Legal entity responsible for the study:
Has not received any funding
All authors have declared no conflicts of interest.
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