JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.
Jpn J Clin Oncol. 2020 Sep 5;50(9):1076-1079. doi: 10.1093/jjco/hyaa092.
The standard treatment for the patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy. However, if patients have idiopathic pulmonary fibrosis combined with early stage lung cancer, there is no standard treatment for this population. Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function; thus, the preservation of respiratory function is essential. The aim of this trial is to confirm the clinical effectiveness of sublobar resection such as wedge resection or segmentectomy for early NSCLC with idiopathic pulmonary fibrosis compared with lobectomy in a randomized phase III trial. The primary endpoint is overall survival. If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis. A planned total 430 patients will be enrolled from 50 institutions over 5 years. This trial has been registered in the UMIN Clinical Trials Registry with code UMIN000032696 [http://www.umin.ac.jp/ctr/index.htm].
对于可手术切除的早期非小细胞肺癌 (NSCLC) 患者，标准治疗方法是肺叶切除术。然而，如果患者患有特发性肺纤维化并伴有早期肺癌，那么针对这一人群尚无标准治疗方法。特发性肺纤维化患者的呼吸功能会出现慢性进行性下降；因此，保留呼吸功能至关重要。本试验的目的是在一项随机 III 期试验中，确认亚肺叶切除术（如楔形切除术或节段切除术）与肺叶切除术相比，治疗特发性肺纤维化合并早期 NSCLC 的临床疗效。主要终点是总生存期。如果证明总生存期和微创性的非劣效性，那么它可能成为特发性肺纤维化合并早期 NSCLC 的新的标准治疗方法。计划在 5 年内从 50 个机构中招募 430 名患者。该试验已在 UMIN 临床试验注册中心注册，注册号为 UMIN000032696 [http://www.umin.ac.jp/ctr/index.htm]。
