A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
- Conditions
- Stage IIIA or stage IIIB gastric cancer
- Registration Number
- JPRN-UMIN000000714
- Lead Sponsor
- OGSG
- Brief Summary
The OS rate at 3 years was 78.4 % [95 % confidence interval (CI), 67.9-90.6 %] and the DFS rate at 3 years was 66.2 % (95 % CI, 54.4-80.7 %).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of the patients who completed the course
- Secondary Outcome Measures
Name Time Method Incidence of adverse events, Time to recurrence, survival, the ratio of the patients who completed the course of TS-1 in a year