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

UMIN ID: UMIN000000553

Registered date:21/12/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: clinical stage I (SM1-2) esophageal cancer
• Date of first enrollment: 2006/12/21
• Target sample size: 82
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A: Combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy

Outcome(s)

• Primary Outcome: 3-year overall survival in 'pM1-3, vascular invasion positive and margin negative cases' or 'pSM1-2 and margin negative cases&#39
• Secondary Outcome: 3-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 minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: National Cancer Center