A Phase III Randomized Trial of Lobectomy Versus Limited Resection for Small-sized Peripheral Non-small Cell Lung Cancer (JCOG0802/WJOG4607L)
A Phase III Randomized Trial of Lobectomy Versus Limited Resection for Small-sized Peripheral Non-small Cell Lung Cancer (JCOG0802/WJOG4607L)
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DOI：
10.1093/jjco/hyp156
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发表时间：
2010-03-01
影响因子：
2.4
通讯作者：
Tsuboi, Masahiro
中科院分区：
文献类型：
--
作者：
Nakamura, Kenichi;Saji, Hisashi;Tsuboi, Masahiro
在日本开始了一项III期研究，以评价在小尺寸（直径< 2 cm）周围型非小细胞肺癌患者中，肺段切除术与肺叶切除术相比在总生存期方面的非劣效性，不包括放射学确定的非浸润性癌症。本研究于2009年8月开始，3年内将从71家机构累计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、胸管放置时间、手术时间、失血量和自动缝合数量。本研究是日本临床肿瘤学组和西日本肿瘤学组在日本开展的首批组间研究之一。
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.