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

Jpn J Clin Oncol. 2009 Oct;39(10):686-9. doi: 10.1093/jjco/hyp078. Epub 2009 Aug 24.

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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Carcinoma* / drug therapy
  • Carcinoma* / radiotherapy
  • Carcinoma* / surgery
  • Clinical Trials, Phase I as Topic
  • Combined Modality Therapy
  • Endoscopy, Gastrointestinal*
  • Esophageal Neoplasms* / drug therapy
  • Esophageal Neoplasms* / radiotherapy
  • Esophageal Neoplasms* / surgery
  • Female
  • Gastric Mucosa / surgery*
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Treatment Outcome
  • Young Adult