A randomized Phase III trial of lobe-specific vs. systematic nodal dissection for clinical Stage I–II non-small cell lung cancer (JCOG1413). (21st November 2017)

• Record Type: Journal Article
• Authors: Hishida, Tomoyuki; Saji, Hisashi; Watanabe, Shun-ichi; Asamura, Hisao; Aokage, Keiju; Mizutani, Tomonori; Wakabayashi, Masashi; Shibata, Taro; Okada, Morihito
• Is Part Of: Japanese journal of clinical oncology. Volume 48:Number 2(2018)
• Page Start: 190
• Page End: 194
• Publication Date: 2017-11-21
• Subjects: non-small-cell lung cancer -- lymph node dissection -- lobe-specific -- systematic -- randomized Phase III study; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyx170
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract : A randomized Phase III trial was commenced to confirm the clinical benefit of lobe-specific nodal dissection in comparison to systematic nodal dissection for clinical Stage I–II non-small cell lung cancer. Abstract: 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. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000025530.