A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)

UMIN ID: UMIN000000861

Registered date:23/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Locally advanced unresectable esophageal cancer in the thorax
• Date of first enrollment: 2004/04/01
• Target sample size: 364
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Standard Dose concurrent chemoradiotherapy (RT: 60Gy/30fr/6w; Cisplatin 70mg/m2 on day 1,29; 5-FU 700mg/m2 on days 1-4, 29-32)
B:Low Dose concurrent chemoradiotherapy (RT: 60Gy/30fr /6w; Cisplatin 4mg/m2 and 5-FU 200mg/m2, 5 days every week, repeatedly for 6 weeks.)

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: complete response rate, treatment completion rate, treatment completion rate by PS, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Simultaneous or metachronous (within 5 years) double cancers 2)Pregnancy or lactation 3)Serious psychiatric illness 4)Steroid treatment 5)HBs antigen positive 6)Uncontrollable diabetes 7)Myocaedial infarcion within 3 months 8)Serious comorbidity 9)Active bacterial or fungous infection

Related Information

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