A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)

UMIN ID: UMIN000000714

Registered date:17/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage IIIA or stage IIIB gastric cancer
• Date of first enrollment: 2007/05/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): DXT 40mg/m2 is administered by drip infusion on day 1. TS-1 80 mg/m2/day is administered orally between day 1 and day 14. It takes 21 days for the one course

Outcome(s)

• Primary Outcome: The ratio of the patients who completed the course
• Secondary Outcome: Incidence of adverse events, Time to recurrence, survival, the ratio of the patients who completed the course of TS-1 in a year

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. with double cancer and/or multiple cancer 2. patients who cannot take TS-1 3. patients who need flucitosine, fenitoin or warfarin 4. with allergic history against medicines 5. with severe allergic response against polysolbate 80 6. without any disorder on the chest X-ray or CT, or interstitial pneumonitis or pulmonary fibrosis 7. with other severe diseases (intestinal paralysis, intestinal obstruction, uncontrolled DM, cardiac failure, or liver dysfunction) 8. watery diarrhea 9. pregnant and/or nursing women 10. men who need their children in future 11. liver cirrhosis or active hepatitis 12. cavity fluid which should be taken out 13. doctors' stop not to register to the study

Related Information

• Primary Sponsor: OGSG
• Source(s) of Monetary Support: NPO Osaka Chinical Study Supporting Organization