Department of Thoracic Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi-ku, Yokohama 241-0815, Japan.
Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22.
A Phase III study was started in Japan to evaluate the non-inferiority in overall survival of segmentectomy compared with lobectomy in patients with small-sized (diameter </=2 cm) peripheral non-small cell lung cancer, excluding radiologically determined non-invasive cancer. This study began in August 2009, and a total of 1100 patients will be accrued from 71 institutions within 3 years. The primary endpoint is overall survival. The secondary endpoints are post-operative respiratory function, relapse-free survival, proportion of local recurrence, adverse events, proportion of patients who complete segmentectomy, duration of hospitalization, duration of chest tube placement, operation time, blood loss and number of auto-sutures used. This study is one of the first intergroup studies in Japan between the Japan Clinical Oncology Group and the West Japan Oncology Group.
一项 III 期研究在日本启动，旨在评估对于直径 ≤2cm 的外周型非小细胞肺癌（不包括影像学诊断为非侵袭性癌的患者），与肺叶切除术相比，解剖性肺段切除术在总生存期方面的非劣效性。这项研究于 2009 年 8 月开始，预计在 3 年内从 71 家机构入组 1100 例患者。主要终点是总生存期。次要终点是术后呼吸功能、无复发生存期、局部复发比例、不良事件、完成肺段切除术的患者比例、住院时间、胸腔引流管放置时间、手术时间、出血量和使用的自动缝合器数量。这项研究是日本临床肿瘤学组与西日本肿瘤学组之间的首次国际多中心研究之一。
