title: 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.
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan. k.takizawa@scchr.jp
authors.forename: Kohei
authors.initials: K
authors.lastname: Takizawa
authors.forename: Atsuo
authors.initials: A
authors.lastname: Takashima
authors.forename: Aya
authors.initials: A
authors.lastname: Kimura
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.forename: Noriaki
authors.initials: N
authors.lastname: Hasuike
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ono
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
authors.forename: Manabu
authors.initials: M
authors.lastname: Muto
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D002454:Cell Differentiation; D002985:Clinical Protocols; D004724:Endoscopy; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000473:pathology / Q000601:surgery*; D006801:Humans; D007564:Japan; D009367:Neoplasm Staging; D011379:Prognosis; D012449:Safety; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*