顺铂不耐受的核心高危头颈癌患者使用西妥昔单抗和多西他赛进行术后生物放化疗：一项2期非随机临床试验方案
Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum-Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial.
作者信息
Nishimura Goshi, Hatakeyama Hiromitsu, Shiono Osamu, Taguri Masataka, Komatsu Masanori, Sano Daisuke, Sakuma Naoko, Yabuki Kenichiro, Arai Yasuhiro, Shibata Kunihiko, Chiba Yoshihiro, Tanabe Teruhiko, Oridate Nobuhiko
机构信息
Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.
Department of Otorhinolaryngology, Yokohama City University Medical Center, Yokohama, Japan.
出版信息
JMIR Res Protoc. 2018 Aug 23;7(8):e11003. doi: 10.2196/11003.
BACKGROUND
We confirmed the safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel in a small number of patients with cis-platinum-intolerant core high-risk head and neck cancer.
OBJECTIVE
To assess treatment efficacy, we planned a phase 2 study of postoperative bio-chemoradiotherapy for patients with cis-platinum-intolerant core high-risk head and neck cancer and will compare the results to those of previously collected radiotherapy data.
METHODS
Patients who underwent definitive surgery for oral cavity, laryngeal, oropharyngeal, or hypopharyngeal advanced cancer, whose postoperative pathological results indicated core high risk for recurrence (eg, positive margin in the primary site or extranodal extension) and who were cis-platinum-intolerant, will undergo postoperative bio-chemoradiotherapy. The primary end point is 2-year disease-free survival.
RESULTS
The expected 2-year disease-free survival is set at 55%, and the calculated sample size is 35 patients, according to a statistical analysis based on previous reports.
CONCLUSIONS
This treatment method is expected to improve the survival rate of patients with severe head and neck cancer.
TRIAL REGISTRATION
UMIN Clinical Trials Registry UMIN000031835; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000036355 (Archived by WebCite at http://www.webcitation.org/71fejVjMr).
背景
我们在少数对顺铂不耐受的核心高危头颈癌患者中证实了使用西妥昔单抗和多西他赛进行术后生物放化疗的安全性。
目的
为评估治疗效果，我们计划对顺铂不耐受的核心高危头颈癌患者进行术后生物放化疗的2期研究，并将结果与之前收集的放疗数据进行比较。
方法
接受口腔、喉、口咽或下咽晚期癌症根治性手术，术后病理结果显示存在复发核心高危因素（如原发部位切缘阳性或结外扩展）且对顺铂不耐受的患者，将接受术后生物放化疗。主要终点是2年无病生存率。
结果
根据基于既往报告的统计分析，预期2年无病生存率设定为55%，计算得出的样本量为35例患者。
结论
这种治疗方法有望提高重度头颈癌患者的生存率。
试验注册
UMIN临床试验注册中心UMIN000031835；https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036355（由WebCite存档于http://www.webcitation.org/71fejVjMr）。
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