title: A non-randomized confirmatory trial of an expanded indication for endoscopic submucosal dissection for intestinal-type gastric cancer (cT1a): the Japan Clinical Oncology Group study (JCOG0607).
abstract: BACKGROUND
  Endoscopic resection has been limited to intestinal-type gastric cancer (cT1a) with a low risk of lymph node metastasis (T1a ≤2 cm, without ulcers). This single-arm confirmatory trial evaluated the efficacy and safety of endoscopic submucosal dissection (ESD) for >2 cm ulcer-negative and ≤3 cm ulcer-positive intestinal-type gastric cancer (cT1a).
  
  
  METHODS
  The eligibility criteria included endoscopically diagnosed cT1a, a single primary intestinal-type gastric adenocarcinoma, an ulcer-negative lesion of any size or a ≤3 cm ulcer-positive lesion, cN0M0, and no prior treatment. If ESD resulted in noncurative resection, surgical resection was added. The primary endpoint was the 5-year overall survival (OS) (planned sample size was 470, with a one-sided alpha level of 2.5%). The threshold 5-year OS was 86.1%.
  
  
  RESULTS
  We enrolled 470 early gastric cancer patients [median tumor size, 25 (5-130) mm] from 29 institutions between June 2007 and October 2010. These patients had 152 ulcer-negative lesions (>2 and ≤3 cm), 111 ulcer-negative lesions (>3 cm), and 207 ulcer-positive lesions (≤3 cm). The success rate for en block resection was 99.1% (466/470). Additional gastrectomy was conducted in 131 patients (28%) who did not fulfill the curative resection criteria. The 5-year OS of all patients was 97.0% (95% confidence interval, 95.0-98.2%), which was higher than the threshold 5-year OS (86.1%). The 317 patients who satisfied the curative resection criteria had no recurrence. There were no ESD-related grade 4 adverse events.
  
  
  CONCLUSIONS
  ESD for early gastric cancers that met the expanded criteria for intestinal-type gastric cancer (cT1a) was acceptable and should be the standard treatment instead of gastrectomy.
authors.affiliation: Gastrointestinal Center and Institute of Minimally Invasive Endoscopic Care (iMEC), Sano Hospital, Kobe, 5-21 Shimizugaoka, Tarumi-Ku, Kobe, 655-0031, Japan. nhasuike11@gmail.com.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Hasuike
authors.affiliation: Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ono
authors.affiliation: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.affiliation: Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Takizawa
authors.affiliation: Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Oda
authors.affiliation: Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Doyama
authors.affiliation: Department of Gastroenterology, Endoscopy Division, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kaneko
authors.affiliation: Department of Endoscopy, Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Hori
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iishi
authors.affiliation: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.affiliation: Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Muto
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D000069916:Endoscopic Mucosal Resection / Q000379:methods*; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*
keywords: Endoscopic submucosal resection; Endoscopy; Gastrectomy; Stomach neoplasms