Tanaka Kiyo, Hanai Nobuhiro, Eba Junko, Mizusawa Junki, Asakage Takahiro, Homma Akihiro, Kiyota Naomi, Fukuda Haruhiko, Hayashi Ryuichi
JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Aichi, Japan.
Jpn J Clin Oncol. 2018 Dec 1;48(12):1105-1108. doi: 10.1093/jjco/hyy125.
For stage I/II tongue cancer patients, it is controversial whether prophylactic neck dissection should be performed with partial glossectomy. Based on the evidence of the primary tumor's depth of invasion as a predictive factor of occult lymph node metastases and a prognostic factor of disease-free survival, randomized phase III trial was initiated in November 2017 to evaluate the omission value for prophylactic neck dissection for stage I/II tongue cancer with 3-10 mm of depth of invasion. In 5 years, 440 patients will be accrued from 28 institutions. The primary end point of the study is the overall survival, whereas the secondary end points are relapse-free survival, local relapse-free survival, proportion of unresectable relapse and of cervical lymph node relapse, post-operative function (paralysis of the accessory and facial nerves and subjective symptoms) and adverse events. This trial has been registered with the UMIN Clinical Trials Registry (registration number: UMIN000030098; http://www.umin.ac.jp/ctr/index.htm).
对于I/II期舌癌患者，在进行部分舌切除术时是否应行预防性颈淋巴结清扫术仍存在争议。基于原发肿瘤浸润深度作为隐匿性淋巴结转移的预测因素及无病生存的预后因素的证据，于2017年11月启动了一项随机III期试验，以评估对浸润深度为3 - 10 mm的I/II期舌癌进行预防性颈淋巴结清扫术的省略价值。5年内，将从28个机构招募440例患者。该研究的主要终点是总生存期，次要终点包括无复发生存期、局部无复发生存期、不可切除复发和颈部淋巴结复发的比例、术后功能（副神经和面神经麻痹及主观症状）以及不良事件。该试验已在日本大学医学情报网络临床试验注册中心注册（注册号：UMIN000030098；http://www.umin.ac.jp/ctr/index.htm）。
