Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)

UMIN ID: UMIN000000737

Registered date:08/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: clinical T1 gastric cancer without submucosal invasion
• Date of first enrollment: 2007/06/01
• Target sample size: 470
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Endoscopic submucal dissection with or without surgical gastrectomy after histological findings.

Outcome(s)

• Primary Outcome: 5-year overall survival (OS)
• Secondary Outcome: OS in UL(-) cases, OS in UL(+) cases, recurrence-free survival (RFS), 5-year RFS with stomach, proportion of one-piece resection, proportion of pathological curative resection after EMR, adverse events, serious adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Impossible to discontinue anticoagulant or antiplatelet medications. 2) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy. 3) Women during pregnancy or breast-feeding. 4) Psychosis. 5) Systemic steroids medication. 6) Active bacterial or fungous infection. 7) History of myocardial infarction or unstable angina pectoris within three months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes mellitus or administration of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare