A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

UMIN ID: UMIN000001913

Registered date:01/05/2009

Basic Information

• Health condition(s) or Problem(s) studied: unresectable or recurrent gastric cancer
• Date of first enrollment: 2008/10/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemotherapy

Outcome(s)

• Primary Outcome: 1 year survival rate
• Secondary Outcome: Overall survival, response rate, progression free survival, time to treatment failure, relation between survival time and G/L ratio

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients who have a contraindication of S-1 or cisplatin 2)Patients who had infection or inflammatory disease 3)Patients who have or had severe heart disease 4)Patients who have severe commplication, such as ileus,intestinal pneumonia,fibroid lung, uncontrolled diabetes mellitus,renal failure, liver cirrhosis and so on 5)massive asites 6)multiple bone metastases 7)brain metastases 8)fresh gastrointestinal bleeding 9)diarrhea 10)mental disorder 11)synchronous multicancer 12)Patients pregnant or in lactation, or wish to become pregnant during this study. Male patients who intend to make someone pregnant during this study 13)Men who want a baby 14)Patient who is judged to be inappropriate for this study by the principal investigator or the doctors in charge

Related Information

• Primary Sponsor: Yamagata University Faculty of Medicine Department of Gastroenterological, General, Breast and Thyroid Surgery
• Source(s) of Monetary Support: Yamagata University Faculty of Medicine Department of Gastroenterological, General, Breast and Thyroid Surgery