Division of Thoracic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
Department of Surgery II, Faculty of Medicine, 2-2-2 Iida-Nishi, Yamagatashi, Yamagata 990-9585, Japan.
Jpn J Clin Oncol. 2024 Aug 14;54(8):926-929. doi: 10.1093/jjco/hyae056.
The goal of postoperative surveillance following non-small cell lung cancer surgery is to detect recurrence and second primary malignancies while curative treatment is still possible. Although several guidelines recommend that patients have computed tomography (CT) scans every 6 months for the first 2 years after resection, then once a year, there is no evidence that it is effective for survival, especially in locally advanced non-small cell lung cancer. In October 2022, we launched a multi-institutional, randomized controlled phase III trial for pathological stage II and IIIA non-small cell lung cancer patients to confirm the non-inferiority of less intensive surveillance with less frequent CT scans versus standard surveillance in terms of overall survival. The primary endpoint is overall survival. We intend to enroll 1100 patients from 45 institutions over 4 years. The trial has been registered in the Japan Registry of Clinical Trials under the code jRCT1030220361 (https://jrct.niph.go.jp/latest-detail/jRCT1030220361).
术后非小细胞肺癌手术后的监测目的是在仍有可能进行治愈性治疗时发现复发和第二原发恶性肿瘤。尽管有几项指南建议患者在切除后前 2 年内每 6 个月进行一次计算机断层扫描（CT），然后每年进行一次，但没有证据表明这对生存有效，尤其是在局部晚期非小细胞肺癌中。2022 年 10 月，我们启动了一项多机构、随机对照 III 期试验，针对病理分期 II 期和 IIIA 期非小细胞肺癌患者，以确认与标准监测相比，采用较少频率 CT 扫描的不那么密集监测在总生存期方面的非劣效性。主要终点是总生存期。我们计划在 4 年内从 45 个机构招募 1100 名患者。该试验已在日本临床试验注册处注册，编号为 jRCT1030220361（https://jrct.niph.go.jp/latest-detail/jRCT1030220361）。
