title: A phase II trial of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma: Japan Clinical Oncology Group Study JCOG0508.
abstract: Standard treatment for clinical stage I esophageal cancer with submucosal invasion (T1b) has been surgical resection. We conducted a Phase II trial to evaluate the efficacy and the safety of combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy for clinical stage I (T1b) esophageal cancer. Patients diagnosed as having clinical stage I (T1b) esophageal cancer which is considered to be resectable by EMR are eligible. When pathological examination of the EMR specimen confirms T1b tumor with negative or positive resection margin, the patient undergoes chemoradiotherapy. The study continues until 82 patients with T1b tumor with negative resection margin are enrolled from 20 institutions. The primary endpoint is 3-year overall survival (OS) in pT1b cases with negative resection margin. The secondary endpoints are 3-year OS and progression-free survival in all eligible cases, OS in pT1a-MM cases with margin-negative, complications of EMR and adverse events of chemoradiotherapy. The data from this trial will be expected to provide a non-surgical treatment option to the patients with clinical stage I (T1b) esophageal cancer.
authors.affiliation: Japan Clinical Oncology Group Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: Manabu
authors.initials: M
authors.lastname: Muto
authors.forename: Keiko
authors.initials: K
authors.lastname: Minashi
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
mesh_terms: D000328:Adult; D000368:Aged; D002277:Carcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D017321:Clinical Trials, Phase I as Topic; D003131:Combined Modality Therapy; D016099:Endoscopy, Gastrointestinal; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
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