NIPH Clinical Trials Search

UMIN ID: UMIN000000714

Registered date:17/05/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedStage IIIA or stage IIIB gastric cancer
Date of first enrollment2007/05/01
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeThe ratio of the patients who completed the course
Secondary OutcomeIncidence 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name Hiroshi Furukawa
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan Japan
Telephone 072-366-0221
Affiliation Kinki University Faculty of Medicen Department of surgery
scientific contact
Name Shigeyuki Tamura
Address 660-8511 3-1-69, Inabaso, Amagasaki-shi, Hyogo Japan
Telephone 06-6416-1221
Affiliation Kansai Rosai Hospital Department of surgery