一项多机构随机III期临床试验:肺叶切除术与节段切除术治疗放射学上以固体为主的非小细胞肺癌,伴磨玻璃样混浊,肿瘤直径为bbb2cm和≤3cm: JCOG2217 (STRONG)。

IF 2.2 4区 医学 Q3 ONCOLOGY
Noriko Mitome, Aritoshi Hattori, Kenji Suzuki, Masashi Wakabayashi, Yuta Sekino, Tetsuya Isaka, Masaya Yotsukura, Keiju Aokage, Haruhiko Fukuda, Shun-Ichi Watanabe
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引用次数: 0

摘要

自1995年的一项随机试验结果以来,肺叶切除术一直是临床分期IA期非小细胞肺癌(NSCLC)的标准手术方法。然而,最近的III期试验已经证明了节段切除术治疗小NSCLC的有效性。对于肿瘤直径≤2cm的周围性肺癌,节段切除术已成为标准治疗方法之一,考虑进一步扩大节段切除术的适应症。我们计划进行这项试验,以证实在具有磨玻璃样混浊、肿瘤直径小于2 cm和≤3 cm的实心型非小细胞肺癌患者的总生存率方面,节段切除术与肺叶切除术的非劣效性。纯实体瘤因其高度恶性的特点而被排除在外。主要终点是总生存期。来自53家机构的515名患者将在5年内入组。该试验已在日本临床试验注册中心注册(研究编号:jRCTs1030240027)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A multi-institutional randomized phase III trial of lobectomy versus segmentectomy for radiologically solid-predominant non-small cell lung cancer with a ground-glass opacity and tumor diameter > 2 cm and ≤ 3 cm: JCOG2217 (STRONG).

Lobectomy has been the standard surgical procedure for clinical stage IA non-small cell lung cancer (NSCLC) since the results of a randomized trial in 1995. However, recent phase III trials have demonstrated the efficacy of segmentectomy for small NSCLC. Segmentectomy has become one of the standard treatments for peripheral lung cancers with a tumor diameter of ≤2 cm and further expansion of the indication for segmentectomy is considered. We planned this trial to confirm the non-inferiority of segmentectomy to lobectomy in terms of overall survival in patients with solid-predominant NSCLC with ground-glass opacity and > 2 cm and ≤ 3 cm in tumor diameter. Pure-solid tumors will be excluded because of their highly malignant characteristics. The primary endpoint is overall survival. A total of 515 patients from 53 institutions will be enrolled over 5 years. The trial has been registered in the Japan Registry of Clinical Trials (study number: jRCTs1030240027).

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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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