病理 II 期和 IIIA 期非小细胞肺癌术后监测随机 III 期试验(JCOG2012,PHOENIX)。

IF 1.9 4区 医学 Q3 ONCOLOGY Japanese journal of clinical oncology Pub Date : 2024-08-14 DOI:10.1093/jjco/hyae056
Kenta Tane, Satoshi Shiono, Masashi Wakabayashi, Tomoko Kataoka, Noriko Mitome, Haruhiko Fukuda, Keiju Aokage, Shun-Ichi Watanabe
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引用次数: 0

摘要

非小细胞肺癌术后监测的目的是在仍有可能进行根治性治疗的情况下检测复发和第二原发恶性肿瘤。虽然一些指南建议患者在切除术后的头两年每6个月进行一次计算机断层扫描(CT),然后每年一次,但目前还没有证据表明这种方法对生存有效,尤其是对局部晚期非小细胞肺癌。2022 年 10 月,我们启动了一项针对病理 II 期和 IIIA 期非小细胞肺癌患者的多机构随机对照 III 期试验,以证实在总生存期方面,较少频率 CT 扫描的强化监测与标准监测相比无劣效性。主要终点是总生存期。我们计划在 4 年内招募来自 45 家机构的 1100 名患者。该试验已在日本临床试验注册中心注册,代码为 jRCT1030220361 (https://jrct.niph.go.jp/latest-detail/jRCT1030220361)。
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A randomized phase III trial of postoperative surveillance for pathological stage II and IIIA non-small cell lung cancer (JCOG2012, PHOENIX).

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).

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来源期刊
CiteScore
3.70
自引率
8.30%
发文量
177
审稿时长
3-8 weeks
期刊介绍: Japanese Journal of Clinical Oncology is a multidisciplinary journal for clinical oncologists which strives to publish high quality manuscripts addressing medical oncology, clinical trials, radiology, surgery, basic research, and palliative care. The journal aims to contribute to the world"s scientific community with special attention to the area of clinical oncology and the Asian region. JJCO publishes various articles types including: ・Original Articles ・Case Reports ・Clinical Trial Notes ・Cancer Genetics Reports ・Epidemiology Notes ・Technical Notes ・Short Communications ・Letters to the Editors ・Solicited Reviews
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