Gastric Cancer
Conditions
Interventions
1st Course (S-1 alone): S-1 80mg/m2 d1-14, q3w 2nd to 7th Course (S-1 plus docetaxel):Docetaxel: 40 mg/m2 (1 hour IV infusion) on Day 1 of each cycle S-1: S-1 dosage is dependent upon BSA calculatio
Sponsors
Japan Clinical Cancer Reseach Organization (JACCRO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven gastric cancer of IIIA, IIIB or IIIC (Histologically Common Type) 2. D2 lymph-node dissection with R0 surgery (with the result of no residual tumor) 3. No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis 4. Age 20 to 80 years. 5. No previous treatment for cancer except for the initial gastric resection for the primary lesion. 6. ECOG performance status 0 or 1. 7. Within 42 days after gastric resection and adequate self-supported nutritional intake. 8. Hgb>9.0 g/dL, WBC 4000-12,000/mm3, ANC> 1500/mm3, platelets> 100,000/mm3 9. Creatinine< 1.2 mg/dL, Creatinine clearance> 50mL/min 10. Total bilirubin< 1.5 X UNL 11. AST (SGOT) and ALT (SGPT)< 100 IU/L 12. Subjects must have fully recovered from surgical damage 13. Written informed consent
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years recurrence free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-years and 5-years overall survival 5-years recurrence free survival time to treatment failure adverse events | — |
Countries
Japan
Contacts
Public ContactMasashi Fujii
Japan Clinical Cancer Reseach Organization (JACCRO) Research Office
Outcome results
None listed