Efficacy of radioactive hypoxia-targeting therapeutic agent 64Cu-ATSM on recurrent malignant glioma: a study protocol for a phase-III, investigator-sponsored, randomized controlled trial.

IF 1.9 4区 医学 Q3 ONCOLOGY
Yayoi Ando, Shunsuke Yanagisawa, Makoto Ohno, Hiroaki Kurihara, Kimiteru Ito, Masahiko Ichimura, Kenta Anjo, Masako Inaba, Yukari Nagasaka, Ryo Sadachi, Taro Shibata, Natsuko Okita, Kenichi Nakamura, Hiroki Matsumoto, Yukie Yoshii, Yoshitaka Narita
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引用次数: 0

Abstract

Previously, we conducted the phase I study of 64Cu-ATSM, which is Cu-diacetyl-bis (N4-methylthiosemicarbazone) radiolabeled with Cu-64, for patients with brain tumors and determined the maximum tolerated dose. We started a subsequent multicenter, randomized, open-label phase III study to evaluate the efficacy of 64Cu-ATSM as an investigator-initiated registration-directed trial for recurrent or residual malignant glioma (protocol No. NCCH2301, STEP-64). Patients will be randomized to either the control or study arm (64Cu-ATSM). A large-scale randomized trial seems difficult to perform for patients with brain tumors because of small sample sizes. Therefore, we designed a small randomized trial with 56 patients. Furthermore, as a pragmatic approach in the control arm, physicians can choose treatments depending on the patient's condition among the clinically available options, where the drugs used are not regarded as investigational. The trial was registered in the Japan Registry of Clinical Trials as jRCT2031240090.

放射性低氧靶向治疗剂64Cu-ATSM对复发性恶性胶质瘤的疗效:一项iii期、研究者赞助的随机对照试验的研究方案
此前,我们对64Cu-ATSM进行了I期研究,该药物是用Cu-64放射标记的cu -二乙酰-双(n4 -甲基硫代氨基脲),用于脑肿瘤患者,并确定了最大耐受剂量。我们随后启动了一项多中心、随机、开放标签的III期研究,以评估64Cu-ATSM作为研究者发起的注册导向试验治疗复发或残留恶性胶质瘤的疗效。NCCH2301,一步- 64)。患者将被随机分配到对照组或研究组(64Cu-ATSM)。由于样本量小,对脑肿瘤患者进行大规模随机试验似乎很困难。因此,我们设计了一项56例患者的小型随机试验。此外,作为一种实用的方法,在对照组中,医生可以根据患者的病情在临床可用的选择中选择治疗方法,其中使用的药物不被视为研究性药物。该试验已在日本临床试验注册中心注册为jRCT2031240090。
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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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