A Phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for Stage III gastric cancer

UMIN ID: UMIN000001584

Registered date:17/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage III gastric cancer
• Date of first enrollment: 2008/12/01
• Target sample size: 49
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): chemotherapy+surgery

Outcome(s)

• Primary Outcome: 3 year progression free survival rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Active bleeding from the tumor 2)Paralysis of intestine or ileus 3)Diarrhea(watery stool) 4)Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium 5)Synchronous multicancer 6)Serous infection 7)Interstitial pneumonitis or fibroid lung 8)Pleural effusion or ascites requiring control 9)Uncontrollable diabetes mellitus, uncontrollable hypertention, heart insufficiency, myocardial infarction within 6 months,uncontrolled arrhythmia or angina 10)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study 11)Patient who has experienced serious drug allergy in the past 12)Patient with severe phyciatric disease 13)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Related Information

• Primary Sponsor: Department of Surgery Graduate School of Medicine, Kyoto University
• Source(s) of Monetary Support: Department of Surgery Graduate School of Medicine, Kyoto University