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Japanese Journal of Clinical Oncology Advance Access published online on November 22, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp156
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© The Author (2009). Published by Oxford University Press. All rights reserved

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

Kenichi Nakamura1, Hisashi Saji2, Ryu Nakajima3, Morihito Okada4, Hisao Asamura5, Taro Shibata1, Shinichiro Nakamura6, Hirohito Tada3 and Masahiro Tsuboi7

1 Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center
2 Department of Thoracic Surgery, Tokyo Medical University Hospital, Tokyo
3 Department of Thoracic Surgery, Osaka City General Medical Center, Osaka
4 Department of Thoracic Surgery, Hiroshima University Hospital, Hiroshima
5 Department of Thoracic Surgery, National Cancer Center Hospital, Tokyo
6 West Japan Oncology Group Data Center
7 Department of Thoracic Surgery, Kanagawa Cancer Center, Yokohama, Japan

For reprints and all correspondence: Masahiro Tsuboi, Department of Thoracic Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi-ku, Yokohama 241-0815, Japan. E-mail: mtsuboi{at}za2.so-net.ne.jp

Received September 30, 2009; accepted October 20, 2009

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.

Key Words: non-small cell lung carcinoma • thoracic surgery • pneumonectomy • clinical trial • Phase III


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