title: A Phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection (JCOG1217, Steroid EESD P3).
abstract: A randomized Phase III trial commenced in Japan in September 2014. Endoscopic local steroid injection has been commonly used and considered acceptable as the current standard treatment for the prevention of esophageal stricture after endoscopic submucosal dissection for superficial esophageal cancer. The purpose of this study is to confirm the superiority of prophylactic oral steroid administration following endoscopic submucosal dissection in terms of stricture-free survival over endoscopic local steroid injection for patients with superficial esophageal cancer. A total of 360 patients will be accrued from 35 Japanese institutions within 2.5 years. The primary endpoint is stricture-free survival, and the secondary endpoints are the number of endoscopic balloon dilations for 12 weeks after endoscopic submucosal dissection, adverse events, serious adverse events and the proportion of patients with dysphagia score ≤1 at 12 weeks after endoscopic submucosal dissection. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015064 (http://www.umin.ac.jp/ctr/index.htm).
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Mizutani
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, Shizuoka ma.tanaka@scchr.jp.
authors.forename: Masaki
authors.initials: M
authors.lastname: Tanaka
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Junko
authors.initials: J
authors.lastname: Eba
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.
authors.forename: Noboru
authors.initials: N
authors.lastname: Hanaoka
authors.affiliation: Department of Gastroenterology, Niigata University Medical and Dental Hospital, Niigata.
authors.forename: Manabu
authors.initials: M
authors.lastname: Takeuchi
authors.affiliation: Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.
authors.forename: Ikuo
authors.initials: I
authors.lastname: Aoyama
authors.affiliation: Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kojima
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, Shizuoka.
authors.forename: Kohei
authors.initials: K
authors.lastname: Takizawa
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, Shizuoka.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ono
authors.affiliation: Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto.
authors.forename: Manabu
authors.initials: M
authors.lastname: Muto
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003680:Deglutition Disorders / Q000209:etiology; D004210:Dissection / Q000009:adverse effects* / Q000379:methods; D004938:Esophageal Neoplasms / Q000150:complications / Q000473:pathology / Q000601:surgery*; D004940:Esophageal Stenosis / Q000209:etiology* / Q000517:prevention & control*; D004945:Esophagoscopy / Q000009:adverse effects; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D007564:Japan; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011322:Primary Prevention / Q000379:methods; D013256:Steroids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D013256:Steroids
keywords: Phase III; esophageal cancer; prophylactic endoscopic local steroid injection therapy; prophylactic oral steroid administration