Advanced gastric cancer
Conditions
Interventions
1.TS-1 80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. 2.PSK 3g, PO from day 1 to 2 years.
Sponsors
Toho University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient who is pathologically confirmed as gastric cancer 2.Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B 3.Patient whose final stage is II (except for T1), IIIA, or IIIB 4.Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis 5.Patient whose age at the registration is ranging between 20 and 80 years old 6.Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy 7.Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration 8.Patient who has no serious concurrent complications, and satisfies the following criteria 9.White blood cell count>= 4,000 /mm3 10.Platelet count: >= 100,000 /mm3 11.Serum total bilirubin: <= 1.5 mg/dL 12.Serum AST (GOT), ALT (GPT): < 2.5 * ULN 13.Serum creatinine: < ULN 14.Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1.Patient with metachronous or synchronous multicancer 2.Patient who contraindicates to TS-1 3.Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium 4.Patient who has experienced serious drug allergy over grade 3 in the past 5.Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency 6.Patient with diarrhea (watery stool) 7.Patient who is pregnant or in lactation, or wish to become pregnant during this study 8.Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-Free Survival 5years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival 5years Drug compliance Adverse events Serial changes of tumor markers | — |
Countries
Japan
Contacts
Public ContactHideaki Shimada
Toho University School of Medicine Department of Surgery
Outcome results
None listed