Gastric cancer
Conditions
Interventions
S-1 was given orally twice daily for the first 2 weeks of a 3-week cycle. The dosage was 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA ranging from 1.25 m2 to less than 1
Sponsors
Department of Surgery, Kochi Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven, Stage III resectable gastric adenocarcinoma. 2. D2 or more extensive 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. An age of 20 years and over. 5. A performance status of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 6. Patients who recived surgery during the previous 6 weeks, being possible peroral administration. 7. No previous treatment for cancer except for the initial gastric resection for the primary lesion. 8. Adequate organ function during the previous 14 days. 9. All patients gave written informed consent.
Exclusion criteria
Exclusion criteria: 1. Synchronous or metachronous malignant disease, or multicentric cancer. 2. Serious postoperative morbidity such as serious infection, anastomotic leakage, gastrointestinal bleeding and so on. 3. Serious concurrent disease such as intestinal palsy, small bowel obstraction, interstitial pneumonia, pulmonary fibrosis, uncontrolable diabetes mellitus, heart failure, renal failure, liver cirrhosis, hepatic failure, and so on. 4. Active infectious disease. 5. Positive of HBs antigen or HCV antibody. 6. Continuous treatment with steroids. 7. Serious diarrhea. 8. A medical history of serious allergy to any drug. 9. Ascites beyond the pelvic cavity or pleural effusion. 10. Brain metastasis. 11. Taking flucytosine or phenytoin. 12. Needs of taking warfarin potassium. 13. Sensory neuropathy caused by any drug. 14. A history of blood transfusion or administration of granulocyte-colony stimulating factor within 3 weeks before enrollment. 15. Women who are pregnant or hope to become pregnant during the study period. 16. Patients judged inappropriate for the study by their physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year Relapse-Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Incidence of Adverse events Grading of neuropathy in each treatment cycle | — |
Countries
Japan
Contacts
Public ContactTsutomu Namikawa
Kochi Medical School Department of Surgery
Outcome results
None listed