Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

UMIN ID: UMIN000000710

Registered date:08/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: esophageal neoplasm
• Date of first enrollment: 2007/05/01
• Target sample size: 81
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Concurrent chemoradiotherapy with S-1 and cisplatin

Outcome(s)

• Primary Outcome: Incidence of dose limiting toxicity/Complete response rate
• Secondary Outcome: Adverse event, Overall survival, Progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Patients requiring the administration of phenytoin or warfarin potassium 3) Pregnant or lactating women or women of childbearing potential 4) Psychosis 5) Patients requiring systemic steroids medication 6) HBs antigen positive 7) Uncontrollable diabetes millutus or requiring administration of insulin 8) Uncontrollable hypertension 9) History of myocardial infarction or unstable angina pectoris 10) Interstitial pneumonia, fibroid lung or severe emphysema 11) Active bacterial or fungous infection

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Center for Clinical Trials, Japan Medical Association