研究方案:局部软组织肉瘤新辅助和辅助化疗与立即手术和辅助化疗的随机III期试验:日本临床肿瘤学小组研究 JCOG2102 (NACLESS)。

IF 1.9 4区 医学 Q3 ONCOLOGY
Yuki Funauchi, Satoshi Tsukushi, Hiroaki Hiraga, Akio Sakamoto, Toshiyuki Kunisada, Akihito Nagano, Koji Hiraoka, Kazutaka Kikuta, Tsukasa Yonemoto, Keisuke Ae, Akira Kawai, Makoto Endo, Yusuke Sano, Ryunosuke Machida, Tetsuya Sekita, Haruhiko Fukuda, Yoshinao Oda, Toshifumi Ozaki, Kazuhiro Tanaka
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引用次数: 0

摘要

高危软组织肉瘤患者的最佳手术时机和围手术期化疗疗程数仍存在争议。新辅助化疗期间肿瘤生长导致部分患者截肢。本研究旨在证实,对于局部高危软组织肉瘤患者,手术和三个疗程的阿霉素(30 毫克/平方米,第 1 天和第 2 天)加伊福酰胺(2 克/平方米,第 1-5 天)辅助化疗与我们的标准治疗方法(三个疗程的新辅助化疗和手术,然后两个疗程的阿霉素加伊福酰胺辅助化疗)相比并无劣势。这是一项多中心、双臂、开放标签、随机III期试验。主要目的是确认总生存期的非劣效性(边缘:危险比为 1.61)。这是首个比较软组织肉瘤新辅助化疗和即刻手术的随机对照试验。该试验于2022年11月16日启动,并在日本临床试验注册中心注册(jRCTs031220446)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS).

The optimal timing of surgery and the number of courses of perioperative chemotherapy for high-risk soft tissue sarcoma patients are still controversial. Tumour growth during neoadjuvant chemotherapy led to limb amputation in some patients. This study aims to confirm the non-inferiority of surgery and three courses of adjuvant chemotherapy with adriamycin (30 mg/m2, days 1 and 2) plus ifosfamide (2 g/m2, days 1-5) compared with our standard treatment of three courses of neoadjuvant chemotherapy and surgery followed by two courses of adjuvant chemotherapy with adriamycin plus ifosfamide for localized high-risk soft tissue sarcoma patients. This is a multi-center, two-arm, open-label, randomized phase III trial. The primary aim is to confirm the non-inferiority in overall survival (margin: hazard ratio of 1.61). This is the first randomized controlled trial to compare neoadjuvant chemotherapy and immediate surgery for soft tissue sarcoma. This trial was initiated on 16 November 2022 and registered with the Japan Clinical Trials Registry (jRCTs031220446).

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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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