Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer

UMIN ID: UMIN000000920

Registered date:02/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 63
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Adjuvant chemotherapy (S-1 monotherapy followed by S-1+CDDP therapy followed by S-1 monotherapy)

Outcome(s)

• Primary Outcome: Treatment compliance with 3 courses of S-1 plus CDDP
• Secondary Outcome: Treatment compliance with 2 courses of S-1 plus CDDP, proportion of patients receiving treatment according to protocol, and adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2)pregnant or breast-feeding women 3)severe mental disease 4)systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 5)other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6)myocardial infarction within the past 6 months 7)Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Source(s) of Monetary Support: none