PDF(Pubmed)
Abstract：
BACKGROUND: Previous studies demonstrated that wedge resection is sufficient for ground glass-dominant lung adenocarcinoma (LUAD) with tumour diameter ≤2 cm, however, the optimal surgical type for ground glass-dominant LUAD with tumour diameter of 2-3 cm remains unclear. The purpose of this trial is to investigate the safety and efficacy of segmentectomy for ground glass-dominant invasive LUAD with tumour size of 2-3 cm.
METHODS: We initiated a phase III trial to investigate whether segmentectomy is suitable for ground glass-dominant invasive LUAD with tumour size of 2-3 cm. This trial plans to enrol 307 patients from multiple institutions including four general hospitals and two specialty cancer hospitals over a period of 5 years. The primary endpoint is 5 year disease-free survival. Secondary endpoints are lung function, 5 year overall survival, the site of tumour recurrence and metastasis, segmentectomy completion rate, radical segmentectomy (R0 resection) completion rate and surgery-related complications.
BACKGROUND: This trial has been approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (reference 2212267-18) and by the institutional review boards of each participating centre. Written informed consent is required from all participants. The study results will be published in a peer-reviewed international journal.
BACKGROUND: NCT05717803.
METHODS: We initiated a phase III trial to investigate whether segmentectomy is suitable for ground glass-dominant invasive LUAD with tumour size of 2-3 cm. This trial plans to enrol 307 patients from multiple institutions including four general hospitals and two specialty cancer hospitals over a period of 5 years. The primary endpoint is 5 year disease-free survival. Secondary endpoints are lung function, 5 year overall survival, the site of tumour recurrence and metastasis, segmentectomy completion rate, radical segmentectomy (R0 resection) completion rate and surgery-related complications.
BACKGROUND: This trial has been approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (reference 2212267-18) and by the institutional review boards of each participating centre. Written informed consent is required from all participants. The study results will be published in a peer-reviewed international journal.
BACKGROUND: NCT05717803.
摘要：
背景：先前的研究表明楔形切除术足以治疗肿瘤直径≤2cm的磨玻璃样肺腺癌（LUAD），然而,目前尚不清楚肿瘤直径为2~3cm的磨玻璃型LUAD的最佳手术类型.这项试验的目的是研究肿瘤大小为2-3cm的磨玻璃主导的侵入性LUAD的节段切除术的安全性和有效性。
方法：我们启动了一项III期试验，以研究肿瘤大小为2-3cm的磨玻璃型浸润性LUAD的节段切除术是否适用。该试验计划在5年内从包括四家综合医院和两家癌症专科医院在内的多家机构招募307名患者。主要终点是5年无病生存期。次要终点是肺功能，5年总生存期,肿瘤复发和转移的部位，节段切除术完成率,根治性节段切除术(R0切除)完成率及手术相关并发症。
背景：本试验已获得复旦大学上海癌症中心伦理委员会（参考文献2212267-18）和各参与中心机构审查委员会的批准。所有参与者都需要书面知情同意书。研究结果将发表在同行评审的国际期刊上。
背景：NCT05717803。
方法：我们启动了一项III期试验，以研究肿瘤大小为2-3cm的磨玻璃型浸润性LUAD的节段切除术是否适用。该试验计划在5年内从包括四家综合医院和两家癌症专科医院在内的多家机构招募307名患者。主要终点是5年无病生存期。次要终点是肺功能，5年总生存期,肿瘤复发和转移的部位，节段切除术完成率,根治性节段切除术(R0切除)完成率及手术相关并发症。
背景：本试验已获得复旦大学上海癌症中心伦理委员会（参考文献2212267-18）和各参与中心机构审查委员会的批准。所有参与者都需要书面知情同意书。研究结果将发表在同行评审的国际期刊上。
背景：NCT05717803。
