A phase II trial of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma: Japan Clinical Oncology Group Study JCOG0508.
A phase II trial of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma: Japan Clinical Oncology Group Study JCOG0508.
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DOI：
10.1093/jjco/hyp078
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发表时间：
2009-10
影响因子：
2.4
通讯作者：
Gastrointestinal Oncology Study Group of Japan Clinical Oncology Group (JCOG)
中科院分区：
文献类型：
--
作者：
Kurokawa Y;Muto M;Minashi K;Boku N;Fukuda H;Gastrointestinal Oncology Study Group of Japan Clinical Oncology Group (JCOG)
临床I期伴有黏膜下浸润（T1b）的食管癌的标准治疗方法一直是手术切除。我们开展了一项II期试验，以评估内镜下黏膜切除术（EMR）联合放化疗治疗临床I期（T1b）食管癌的疗效和安全性。被诊断为临床I期（T1b）且认为可通过EMR切除的食管癌患者符合入选条件。当EMR标本的病理检查证实为T1b肿瘤且切缘阴性或阳性时，患者接受放化疗。该研究持续进行，直至从20家机构招募到82名切缘阴性的T1b肿瘤患者。主要终点是切缘阴性的pT1b病例的3年总生存率（OS）。次要终点是所有符合条件病例的3年总生存率和无进展生存率、切缘阴性的pT1a - MM病例的总生存率、EMR的并发症以及放化疗的不良事件。预计该试验的数据将为临床I期（T1b）食管癌患者提供一种非手术治疗选择。
Standard treatment for clinical stage I esophageal cancer with submucosal invasion (T1b) has been surgical resection. We conducted a Phase II trial to evaluate the efficacy and the safety of combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy for clinical stage I (T1b) esophageal cancer. Patients diagnosed as having clinical stage I (T1b) esophageal cancer which is considered to be resectable by EMR are eligible. When pathological examination of the EMR specimen confirms T1b tumor with negative or positive resection margin, the patient undergoes chemoradiotherapy. The study continues until 82 patients with T1b tumor with negative resection margin are enrolled from 20 institutions. The primary endpoint is 3-year overall survival (OS) in pT1b cases with negative resection margin. The secondary endpoints are 3-year OS and progression-free survival in all eligible cases, OS in pT1a-MM cases with margin-negative, complications of EMR and adverse events of chemoradiotherapy. The data from this trial will be expected to provide a non-surgical treatment option to the patients with clinical stage I (T1b) esophageal cancer.
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影响因子：
3.8
作者：
Kodama, M;Kakegawa, T
通讯作者：
Kakegawa, T
影响因子：
158.5
作者：
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作者：
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