Sekino Yuta, Hishida Tomoyuki, Yoshioka Hiroshige, Wakabayashi Masashi, Mitome Noriko, Shiono Satoshi, Kenmotsu Hirotsugu, Nosaki Kaname, Aokage Keiju, Horinouchi Hidehito, Fukuda Haruhiko, Ohe Yuichiro, Watanabe Shun-Ichi
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Division of Thoracic Surgery, Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Jpn J Clin Oncol. 2025 Feb 4;55(2):176-182. doi: 10.1093/jjco/hyae143.
In patients with non-small cell lung cancer (NSCLC) who present with radiologically undetermined malignant pleural dissemination or incidental surgical diagnosis of the same, surgery is generally not the preferred option; systemic therapy is favoured. However, there is no consensus on incorporating primary site resection into the treatment plan. Retrospective analyses hint at potential benefits of combining systemic therapy with primary site resection, but prospective studies have yet to confirm these findings. Consequently, we have planned a multicentre, open-label, randomized controlled phase III trial to assess the efficacy of adding primary site resection to standard systemic therapy for stage IVA (cT1-2bN0-1M1a) NSCLC patients with radiologically undetermined pleural dissemination. The primary endpoint is overall survival. We aim to enroll 170 patients from 71 institutions over 5 years. This trial is registered at the Japan Registry of Clinical Trials (jRCT) under study number jRCTs031220666.
对于出现影像学检查无法确定的恶性胸膜播散或偶然手术诊断为恶性胸膜播散的非小细胞肺癌（NSCLC）患者，手术通常不是首选方案；全身治疗更受青睐。然而，对于将原发部位切除纳入治疗方案尚无共识。回顾性分析提示全身治疗与原发部位切除联合可能有益，但前瞻性研究尚未证实这些发现。因此，我们计划开展一项多中心、开放标签、随机对照III期试验，以评估在标准全身治疗基础上加用原发部位切除对影像学检查无法确定胸膜播散的IVA期（cT1-2bN0-1M1a）NSCLC患者的疗效。主要终点是总生存期。我们的目标是在5年内从71个机构招募170名患者。该试验已在日本临床试验注册中心（jRCT）注册，注册号为jRCTs031220666。
