Stage III gastric cancer
Conditions
Interventions
At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest. At the second course, S-1 with CDDP adjuvant chemotherapy is conducted. S-1 is orally admin
Sponsors
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) confirmed gastric cancer by endscopic biopsy 2) >=D2 lymph node dissection, R0 resection 3) Stage III 4) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology 5) age: >=20 and <80 6) possible to oral intake 7) No prior treatment except to surgery 8) sufficient function of important organs 9) written informed consent
Exclusion criteria
Exclusion criteria: 1) with serious complications (intestinal paralysis, ileus, interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure etc) with history of severe drug allergy 2) with clinically important infection 3) with diarrhea 4) with gastrointestinal bleeding need to repeat blood transfusion 5) with hepatocirrhosis or icterus 6) with clinically important mental disorder need to treat 7) with clinically important heart disease need to treat (ischemic heart disease, cardiac dysrhythmia etc) 8) with uncontrollable diabetes mellitus 9) pregnant or nursing women or women who like be pregnant and willing to get pregnant 10) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| estimate the maximum tolerated dose(MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan
Contacts
Public ContactTsunehiro Takahashi
School of Medicine, Keio University Departent of Surgery
Outcome results
None listed