A Phase II Clinical Trial of Endoscopic Submucosal Dissection for Early Gastric Cancer of Undifferentiated Type: Japan Clinical Oncology Group Study JCOG1009/1010

Abstract

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 study will enroll a total of 325 patients from 51 institutions over a 4-year period. The primary endpoint is proportion of 5-year overall survival (% 5-year overall survival) in patients with undifferentiated dominant type. The secondary endpoints are overall survival, relapse-free survival, distant metastasis-free survival, % 5-year overall survival without either recurrence or 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 with pathologically curative resection with endoscopic submucosal dissection and adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN000004995.

Clinical outcomes of early gastric cancer patients after noncurative endoscopic submucosal dissection in a large consecutive patient series

“…Thus, a prospective multicenter nationwide study over a period of 5 years is required to evaluate the clinical outcomes of noncurative gastric ESD patients more precisely. Several multicenter prospective studies are being conducted [33][34][35]. Second, we did not directly identify EGC patients at relatively low risk of metastasis who could be followed up without additional surgery; instead we focused on noncurative EGC patients at high risk of metastasis and gastric-cancer-related death.…”

A case of local recurrence and distant metastasis following curative endoscopic submucosal dissection of early gastric cancer

“…However, all data were retrospective. A few prospective studies were introduced to evaluate the short-term and long-term outcomes of ESD for EGC in Japan [15][16][17]. JCOG0607 includes patients who had clinically diagnosed differentiated-type intramucosal cancers [2 cm in size without ulceration or B3 cm in size with ulceration [15].…”

Incidence of lymph node metastasis in intramucosal gastric cancer measuring 30 mm or less, with ulceration; mixed, predominantly differentiated-type histology; and no lymphovascular invasion: a multicenter retrospective study

“…As endoscopic submucosal dissection (ESD) [1] is well established and widely used in Japan, clinical studies to evaluate the expanded indications have been conducted [2][3][4]. ESD enables the complete removal of large lesions, in contrast to endoscopic mucosal resection (EMR), and hence allows detailed histopathological evaluation [5].…”