JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Department of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.
Jpn J Clin Oncol. 2021 May 28;51(6):999-1003. doi: 10.1093/jjco/hyab037.
The standard treatment for pathological N2 Stage III non-small cell lung cancer with negative surgical margins in Japan is cisplatin-based adjuvant chemotherapy. However, recent studies suggest that the addition of thoracic radiotherapy after adjuvant chemotherapy prolongs survival. While thoracic radiotherapy is considered to prolong survival by improving locoregional control, it is known to increase radiation-induced adverse events. We began a randomized controlled trial in January 2021 in Japan to confirm the superiority of radiotherapy over observation after adjuvant chemotherapy in pathological N2 Stage III non-small cell lung cancer patients with negative surgical margins. We aim to accrue 330 patients from 47 institutions over 5 years. The primary endpoint is relapse-free survival; the secondary endpoints are overall survival, proportion of patients completing radiotherapy in the radiotherapy arm, early adverse events, late adverse events in the radiotherapy arm, serious adverse events and local recurrence.
日本对于切缘阴性的病理 N2 期 III 期非小细胞肺癌的标准治疗是含铂辅助化疗。然而，最近的研究表明，辅助化疗后加用胸部放疗可以延长生存。虽然胸部放疗被认为通过改善局部区域控制来延长生存，但它会增加放射性不良反应。我们于 2021 年 1 月在日本开始了一项随机对照试验，以确认在切缘阴性的病理 N2 期 III 期非小细胞肺癌患者中，辅助化疗后放疗优于观察。我们计划在 5 年内从 47 家机构招募 330 名患者。主要终点是无复发生存率；次要终点是总生存、放疗组中完成放疗的患者比例、早期不良反应、放疗组的晚期不良反应、严重不良事件和局部复发。
