A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study)
A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study)
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DOI：
10.1093/jjco/hyv134
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发表时间：
2015-11-01
影响因子：
2.4
通讯作者：
Sasako, Mitsuru
中科院分区：
文献类型：
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作者：
Kataoka, Kozo;Tokunaga, Masanori;Sasako, Mitsuru
在日本，S-1加顺铂的术前化疗被认为是可接受的，可作为伴有广泛淋巴结转移的胃癌患者的标准治疗选择之一。在化疗基础上加用曲妥珠单抗对HER 2阳性晚期胃癌患者有效，我们于2015年3月开始了一项随机II期试验，以评价S-1加顺铂加曲妥珠单抗与S-1加顺铂单药相比，在HER 2阳性胃癌ELM患者的新辅助治疗背景下，随后使用S-1进行1年的辅助化疗。在3年内，将从41家日本机构中累积总计130例患者。主要终点是总生存期。次要终点为无进展生存期、术前化疗缓解率、R 0切除患者比例、完成术前化疗和手术的患者比例、完成方案治疗（包括术后化疗）的患者比例、病理缓解率和不良事件。该试验已在UMIN临床试验注册中心注册为UMIN 000016920。
Pre-operative chemotherapy with S-1 plus cisplatin is considered to be acceptable as one of the standard treatment options for gastric cancer patients with extensive lymph node metastases in Japan. Addition of trastuzumab to chemotherapy is shown to be effective for HER2-positive advanced gastric cancer patients, and we have commenced a randomized Phase II trial in March 2015 to evaluate S-1 plus cisplatin plus trastuzumab compared with S-1 plus cisplatin alone in the neoadjuvant setting for HER2-positive gastric cancer patients with ELM, which are followed by adjuvant chemotherapy with S-1 for 1 year. A total of 130 patients will be accrued from 41 Japanese institutions over 3 years. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, proportion of patients with R0 resection, proportion of patients who complete the pre-operative chemotherapy and surgery, proportion of patients who complete the protocol treatment including post-operative chemotherapy, pathological response rate and adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN 000016920.