| Theme | The Guidelines of ESD/EMR for Early Gastric Cancer | |
|---|---|---|
| Title | A Phase II Clinical Trial of Endoscopic Submucosal Dissection for Early Gastric Cancer of Undifferentiated Type : Japan Clinical Oncology Group Study JCOG1009/1010 | |
| Publish Date | 2015/06 | |
| Author | Kohei Takizawa | Endoscopy Division, Shizuoka Cancer Center |
| Author | Noriaki Hasuike | Gastrointestinal Center, Sano Hospital |
| Author | Hiroyuki Ono | Endoscopy Division, Shizuoka Cancer Center |
| Author | Masanori Terashima | Division of Gastric Surgery, Shizuoka Cancer Center |
| [ Summary ] | A phase II clinical trial has been initiated to evaluate the efficacy and safety of endoscopic submucosal dissection for intramucosal (cT1a) gastric cancer of undifferentiated type. Patients with cT1a gastric cancer with undifferentiated type adenocarcinoma are eligible for the study. The tumor size should be 2 cm or less without ulceration. The primary endpoint is the 5‒year overall survival rate (% 5‒year overall survival) in patients with undifferentiated dominant type cancer. The secondary endpoints are overall survival, relapse‒free survival, distant metastasis‒free survival, % 5‒year overall survival without recurrence and not requiring gastrectomy, % en bloc resection with endoscopic submucosal dissection, % pathological curative resection with endoscopic submucosal dissection, % 5‒year overall survival in patients with differentiated dominant type, % 5‒year overall survival in patients receiving pathologically curative resection with endoscopic submucosal dissection, and adverse events. The study enrolled a total of 346 patients from 53 institutions over a 2‒year period. The results will come out in 2018. According to a multicenter retrospective analysis, mixed type intramucosal gastric cancer with a predominantly differentiated component, less than 30 mm in size, with ulceration, and without lymphovascular invasion has a very low risk of lymph node metastasis, and this cancer could be managed by curative resection after endoscopic submucosal dissection. |
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