A Phase III Randomized Trial of Lobectomy Versus Limited Resection for Small-sized Peripheral Non-small Cell Lung Cancer (JCOG0802/WJOG4607L)

被引:460
作者
Nakamura, Kenichi [2 ]
Saji, Hisashi [3 ]
Nakajima, Ryu [4 ]
Okada, Morihito [5 ]
Asamura, Hisao [6 ]
Shibata, Taro [2 ]
Nakamura, Shinichiro [7 ]
Tada, Hirohito [4 ]
Tsuboi, Masahiro [1 ]
机构
[1] Kanagawa Canc Ctr, Dept Thorac Surg, Asahi Ku, Yokohama, Kanagawa 2410815, Japan
[2] Natl Canc Ctr, Ctr Canc Control & Informat Serv, Clin Trials & Practice Support Div, Tokyo 104, Japan
[3] Tokyo Med Univ Hosp, Dept Thorac Surg, Tokyo, Japan
[4] Osaka City Gen Med Ctr, Dept Thorac Surg, Osaka, Japan
[5] Hiroshima Univ Hosp, Dept Thorac Surg, Hiroshima, Japan
[6] Natl Canc Ctr, Dept Thorac Surg, Tokyo, Japan
[7] W Japan Oncol Grp Data Ctr, Yokohama, Kanagawa, Japan
关键词
non-small cell lung carcinoma; thoracic surgery; pneumonectomy; clinical trial; Phase III;
D O I
10.1093/jjco/hyp156
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:271 / 274
页数:4
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