NIPH Clinical Trials Search

UMIN ID: UMIN000000553

Registered date:21/12/2006

Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedclinical stage I (SM1-2) esophageal cancer
Date of first enrollment2006/12/21
Target sample size82
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: Combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy


Primary Outcome3-year overall survival in 'pM1-3, vascular invasion positive and margin negative cases' or 'pSM1-2 and margin negative cases'
Secondary Outcome3-year overall survival in all registered cases, progression-free survival in all registered cases, overall survival in pM1-3 and margin negative cases, overall survival in pM1-3, vascular invasion positive and margin negative cases, adverse events of EMR, adverse events of chemoradiotherapy

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) Iodine allergy 2) Impossible to discontinue anticoagulant or antiplatelet medications 3) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy 4) Women during pregnancy or breast-feeding 5) Psychosis 6) Systemic steroids medication 7) HBs antigen positive 8) Active bacterial or fungous infection 9) History of myocardial infarction within three months or unstable angina pectoris 10) Uncontrollable hypertension 11) Uncontrollable diabetes millutus or administration of insulin 12) Interstitial pneumonia, fibroid lung or severe emphysema

Related Information


public contact
Name Keiko Minashi
Address 666-2,Nitona-cho,Chuo-ku,Chiba,Chiba 260-8717,Japan Japan
Telephone 043-264-5431
Affiliation JCOG0508 Coordinating Office Chiba Cancer Center Hospital
scientific contact
Name Manabu Muto
Address 54 Kawaramachi, Shougoin, Kyoto 606-8507, JAPAN Japan
Telephone 075-751-4319
Affiliation Kyoto University Hospital Therapeutic Oncology