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

作者：Kenichi Nakamura, Hisashi Saji, R. Nakajima, M. Okada, Hisao Asamura, Tatsuhiro Shibata, Shinichiro Nakamura, Hirohito Tada, Masahiro Tsuboi · 发表于：Japanese Journal of Clinical Oncology · 年份：2009 · DOI：10.1093/jjco/hyp156 · 被引用次数：528 · 研究领域：Lung Cancer Diagnosis and Treatment、Lung Cancer Treatments and Mutations、Actinomycetales infections and treatment

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.