A randomized Phase III trial of lobe-specific vs. systematic nodal dissection for clinical Stage I-II non-small cell lung cancer (JCOG1413)

作者：Hishida Tomoyuki^*; Saji Hisashi; Watanabe Shun-ichi; Asamura Hisao; Aokage Keiju; Mizutani Tomonori; Wakabayashi Masashi; Shibata Taro; Okada Morihito

来源：Japanese Journal of Clinical Oncology, 2018, 48(2): 190-194.

DOI：10.1093/jjco/hyx170

• non-small-cell lung cancer
• lymph node dissection
• lobe-specific
• systematic
• randomized Phase III study

In January 2017, the Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group commenced a randomized Phase III trial to confirm the clinical benefit of lobe-specific nodal dissection for clinical Stage I-II non-small cell lung cancer. The primary endpoint is overall survival, and the main objective is to confirm the non-inferiority of lobe-specific in comparison to systematic nodal dissection with regard to lobectomy. The secondary endpoints are relapse-free survival, % local recurrence, % regional lymph node recurrence, operation time, blood loss, length of hospitalization, duration of chest tube placement and adverse events. A total of 1700 patients will be accrued from 44 Japanese institutions within 5 years. This study is the first and large prospective trial to evaluate whether the difference in the area of nodal dissection affects the overall survival of patients with relatively early-stage non-small cell lung cancer.

• 出版日期2018-2