Gastric Cancer
Conditions
Interventions
UFT alone UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x6
S1 alone(control) S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x8
Paclitaxel- UFT sequential Paclitaxel 80 mg/m2 Day 1, 8 for the
14 day interval UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x3
Paclitaxel- TS-1 sequential Paclitaxel 80 mg/m2 Day 1, 8 for the first 3 weeks, Day 1, 8, 15 every 4 weeks
14 day interval S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x4
Sponsors
Young Leaders' Program (YLP), Nagoya University School of Medicine
EBM Cooperative Research Center, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven adenocarcinoma of the stomach Clinical and surgical findings of T3 or T4, N0-2, P0, M0 Underwent D2, D1 + #7 or D1 + #7-8 gastrectomy (R0 or R1) No prior chemotherapy or radiotherapy Age ranging between 20 and 80 Preoperative ECOG performance status 0-1 Sufficient organ functions before chemotherapy Able to start chemotherapy between 14 and 56 days after surgery Without synchronous or metachronous cancer (synchronous multiple cancers in the stomach included) Written informed consent. Recovered from or no operative complications Oral food intake possible Laboratory data WBC >/= 3,000 /mm3 and </=12,000 /mm3 neutrocytes >/=1,500 / mm3 Platelets >/=100,000 /mm3 hemoglobin >/=8.0 g/dL Albumin >/=3.0 g/dL; GOT </=100 IU; GPT </=100 IU Bilirubin </=1.5 mg/dL Creatinine </=1.5 mg/dL
Exclusion criteria
Exclusion criteria: Serious complications including ischemic heart disease and arrhythmia which require treatment History of myocardial infarction in 6 months Liver disease under treatment Pneumonitis or lung fibrosis in need for oxygen therapy Gastrointestinal bleeding in need for repeated blood transfusion Psychological disease which require treatment Diabetes mellitus under treatment Bowel obstruction or ileus Medical history of allergy or hypersensitivity to any drugs Hypersensitivity to Cremophor EL Acute inflammation Pregnancy Synchronous malignancies that may affect survival or adverse events Patients judged inappropriate for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease- free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, overall survival and proportion of patients who completed the protocol treatment. | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical Research Information Network (ECRIN) Aichi Devision
Outcome results
None listed