Li Hanyue, Wang Yiyang, Chen Yang, Zhong Chenxi, Fang Wentao
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Front Oncol. 2023 Jan 19;13:1052796. doi: 10.3389/fonc.2023.1052796. eCollection 2023.
With widely use of computed tomography (CT) screening, an increasing number of early-stage lung cancers appearing as ground glass opacity (GGO) have been detected. Therefore, attempts have been made to investigate the feasibility of segmentectomy instead of lobectomy for those patients with GGO. However, the two recently released phase III trials failed to distinguish between GGO-containing lesions from pure solid nodules in the inclusion criteria, and the surgical methods did not distinguish between minimally invasive surgery and open thoracotomy. In addition, total lesion size≤ 2cm was taken as the inclusion criterion, instead of the solid part size recommended in the eighth edition of Union for International Cancer Control/International Association for the Study of Lung Cancer/American Joint Committee on Cancer (UICC/IASLC/AJCC) staging system. Hence, this present trial aims to figure out whether minimally invasive segmentectomy shows superiority in perioperative outcomes and non-inferiority in oncological prognosis over minimally invasive lobectomy among patients with GGO-containing clinical stage T1a-T1b lung invasive adenocarcinoma (IADC).
METHODS/DESIGN: Sample sizes are 1024 patients, who will be randomized into minimally invasive segmentectomy and lobectomy groups . Patients will be collected from 19 hospitals in China. Patients with peripheral mixed ground glass opacity (mGGO) with 0.5cm<total lesion size ≤ 3cm and 0.5cm<solid component size ≤ 2cm in lung window on CT scan are enrolled. The primary endpoint is 5-year recurrence-free survival (RFS). The secondary endpoints are 5-year overall survival (OS), perioperative outcomes and pulmonary function preservation. Kaplan-Meier curves are plotted to compare the survival outcomes between the two arms. Subgroup analyses are also performed to investigate the benefit of segmentectomy among different clinical variables.
If the primary endpoint shows at least non-inferiority in 5-year RFS of segmentectomy to lobectomy, minimally invasive segmentectomy can be recommended as an alternative to minimally invasive lobectomy. If second endpoints show non-inferior 5-year OS along with better perioperative outcomes and/or better pulmonary function preservation of segmentectomy compared with lobectomy after the primary endpoint has reached, minimally invasive segmentectomy may become a preferred procedure for patients with GGO-containing clinical stage T1a-T1b IADCs.
Chinese Clinical Trial Registry. Trial registration number: ChiCTR2000037065.
https://www.chictr.org.cn/, identifier ChiCTR2000037065.
随着计算机断层扫描（CT）筛查的广泛应用，越来越多表现为磨玻璃影（GGO）的早期肺癌被检测出来。因此，人们尝试探讨对这些GGO患者行肺段切除术而非肺叶切除术的可行性。然而，最近公布的两项III期试验在纳入标准中未能区分含GGO的病变与纯实性结节，且手术方式未区分微创手术和开胸手术。此外，将总病灶大小≤2cm作为纳入标准，而非国际癌症控制联盟/国际肺癌研究协会/美国癌症联合委员会（UICC/IASLC/AJCC）第八版分期系统推荐的实性部分大小。因此，本试验旨在明确对于临床分期为T1a - T1b期的含GGO的肺浸润性腺癌（IADC）患者，微创肺段切除术在围手术期结局方面是否显示出优越性，以及在肿瘤学预后方面是否不劣于微创肺叶切除术。
方法/设计：样本量为1024例患者，将被随机分为微创肺段切除术组和肺叶切除术组。患者将从中国的19家医院收集。纳入CT扫描肺窗显示外周混合性磨玻璃影（mGGO）且总病灶大小0.5cm＜总病灶大小≤3cm、实性成分大小0.5cm＜实性成分大小≤2cm的患者。主要终点是5年无复发生存期（RFS）。次要终点是5年总生存期（OS）、围手术期结局和肺功能保留情况。绘制Kaplan - Meier曲线以比较两组的生存结局。还将进行亚组分析以研究肺段切除术在不同临床变量中的获益情况。
如果主要终点显示肺段切除术的5年RFS至少不劣于肺叶切除术，则可推荐微创肺段切除术作为微创肺叶切除术的替代方案。如果在达到主要终点后，次要终点显示肺段切除术的5年OS不劣于肺叶切除术，且围手术期结局更好和/或肺功能保留更好，则微创肺段切除术可能成为临床分期为T1a - T1b期含GGO的IADC患者的首选手术方式。
中国临床试验注册中心。试验注册号：ChiCTR2000037065。
