Department of Clinical Oncology, Kawasaki Medical School Hospital, Kurashiki, Japan.
Department of Surgery, Okayama Rosai Hospital, Okayama, Japan.
BMC Cancer. 2019 Oct 11;19(1):941. doi: 10.1186/s12885-019-6163-6.
Paclitaxel is used in second-line conventional chemotherapies to manage patients with unresectable advanced gastric cancer (GC). Paclitaxel-induced peripheral neuropathy is a known adverse event leading to treatment discontinuation. Additionally, oxaliplatin which causes irreversible peripheral neuropathy is now commonly used in first-line chemotherapy for advanced GC in Japan. Thus, examining the incidence of peripheral neuropathy with paclitaxel after oxaliplatin is necessary to improve the quality of life and outcomes of patients with advanced GC in the second-line treatment setting.
This prospective observational multicenter study, (which we named IVY study), will evaluate the degree of chemotherapy-induced peripheral neuropathy (CIPN) and the efficacy of second-line chemotherapy for unresectable advanced GC. A patient neurotoxicity questionnaire (PNQ) and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) will be used to assess CIPN during the second-line treatment. The key eligibility criteria are as follows: 1) unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach, 2) age over 20 years, 3) Eastern Cooperative Oncology Group performance status score of 0-2, 4) written informed consent following full study information is provided to the patient, 5) progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC. 6) presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging. A total of 200 patients is considered to be appropriate for inclusion in this study.
The results of this study will provide some information on CIPN with the sequential usage of oxaliplatin as first-line chemotherapy to paclitaxel as second-line chemotherapy in clinical practice.
This trial is registered in the University Hospital Medical Information Network's Clinical Trials Registry with the registration number UMIN000033376 (Registered 11 July 2018).
紫杉醇被用于二线常规化疗以治疗不可切除的晚期胃癌（GC）患者。紫杉醇引起的周围神经病变是一种已知的不良事件，可导致治疗中断。此外，奥沙利铂引起的不可逆周围神经病变现在常用于日本晚期 GC 的一线化疗。因此，在奥沙利铂之后用紫杉醇检查周围神经病变的发生率，对于提高二线治疗晚期 GC 患者的生活质量和结果是必要的。
这项前瞻性观察性多中心研究（我们命名为 IVY 研究）将评估不可切除的晚期 GC 二线化疗引起的化疗诱导的周围神经病变（CIPN）程度和疗效。将使用患者神经毒性问卷（PNQ）和癌症治疗功能评估/妇科肿瘤组-神经毒性（FACT/GOG-Ntx）来评估二线治疗期间的 CIPN。主要入选标准如下：1）组织学证实为原发性胃腺癌的不可切除或复发性 GC；2）年龄超过 20 岁；3）东部合作肿瘤组表现状态评分 0-2 分；4）向患者提供完整的研究信息后，签署书面知情同意书；5）氟嘧啶和铂类抗癌药物（顺铂或奥沙利铂）一线化疗进展或不耐受晚期 GC；6）存在可评估的病变，通过计算机断层扫描（CT）或磁共振成像确认。这项研究预计共纳入 200 例患者。
这项研究的结果将提供一些关于在临床实践中奥沙利铂作为一线化疗，紫杉醇作为二线化疗的顺序使用时 CIPN 的信息。
这项试验在大学医院医疗信息网络的临床试验注册中心注册，注册号为 UMIN000033376（注册于 2018 年 7 月 11 日）。
