A Phase III Study of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-UMIN000010337
- Lead Sponsor
- Japan Clinical Cancer Reseach Organization (JACCRO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1100
Not provided
1. Active double cancer (except focal cancer in adenoma of colorectal cancer and carcinoma in situ of cervical cancer) and/or past history of other cancer. 2. Patients with severe postoperative complication (severe postoperative infections, anastomotic leakage, gastrointestinal bleeding). 3. Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, uncontrolled hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.). 4. Patient with active infectious desease. 5. Patient with positive HBs antigen or positive HCV antibody. 6. Definite contraindications for the use of corticosteroids. 7. History of hypersensitivity to fluoropyrimidines, docetaxel, or medications formulated with polysorbate 80, other severe drug induced allergy or . 8. History of allergy of both iodine and gadolinium. 9. Patient is taking flucytosine. 10. Pregnancy or lactation women, women with suspected pregnancy or men with willing to get pregnant. 11. Patient with psychosis or psychotic symptoms and judged to be difficult to determine participating clinical trial. 12. Any subject judged by the investigator to be unfit for any reason to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-years recurrence free survival rate
- Secondary Outcome Measures
Name Time Method 3-years and 5-years overall survival 5-years recurrence free survival time to treatment failure adverse events