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.
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.
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术后使用西妥昔单抗和多西他赛的生物化疗法在CIS-铂 - 智力 - 智力高风险头部和颈部癌症患者中：2期非机制临床试验的方案。
DOI：
10.2196/11003
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发表时间：
2018-08-23
影响因子：
1.7
通讯作者：
Oridate N
中科院分区：
文献类型：
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作者：
Nishimura G;Hatakeyama H;Shiono O;Taguri M;Komatsu M;Sano D;Sakuma N;Yabuki K;Arai Y;Shibata K;Chiba Y;Tanabe T;Oridate N
我们证实了西妥昔单抗和多西他赛在少数顺铂不耐受的核心高危头颈癌患者中术后生物放化疗的安全性。为了评估治疗效果，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，并将结果与先前收集的放疗数据进行比较。接受口腔、喉、口咽或下咽晚期癌症的确定性手术的患者，其术后病理结果表明复发的核心高风险（例如，原发部位或结节性扩展的阳性边缘）以及顺铂不耐受的患者，将接受术后生物化学放射治疗。主要终点是2年无病生存期。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%，计算样本量为35例患者。这种治疗方法有望提高重度头颈癌患者的生存率。UMIN临床试验注册中心UMIN 000031835; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi？recptno= R 000036355（WebCite存档，网址：http：//www.webcitation.org/71fejVjMr）
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. 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. 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. 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. This treatment method is expected to improve the survival rate of patients with severe head and neck cancer. 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)