Gastric cancer
Conditions
Interventions
S-1 80 mg/m2 PO BID days 1-14 Docetaxel 40 mg/m2 DIV day 1 Cisplatin 60 mg/m2 DIV day 1 every 28 days
Sponsors
Department of Gastroenterology, Kitasato University School of Medicine
Kanagawa Cancer Center Kitasato university Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric adenocarcinoma 2) Measurable disease by Response Evaluation Criteria in Solid Tumors Group (RECIST) 3) No prior chemotherapy or radiation therapy for gastric cancer 4) Age between 20 and 80 years 5) Adequate organ function 1. WBC >=3,000/mm3, 2. platelets >=100,000/mm3 3. T-Bil <=1.5 mg/dL 4. GOT, GPT <=100 U/L 5. Cr <=1.5 mg/dL 6. creatinine clearance >50ml/min 7. normal ECG 6) ECOG performance status (PS) of 0 to 2 7) Oral food intake possible 8) A life expectancy of at least 8 weeks 9) Written informed
Exclusion criteria
Exclusion criteria: 1)Patients contraindicated to docetaxel,cisplatin,S-1 2)Active infection 3)Severe heart disease 4)Uncontrolled medical conditions (paralytic ileus,bowel obstruciton,interstitial pneumonia,pulmonary fibrosis,uncontrollable diabetes mellitus,renal failure,liver cirrhosis) 5)Massive abdominal effusion or massive pleural effusion 6)Extensive bone metastasis 7)Symptomatic brain metastasis 8)Severe diarrhea 9)Severe mental disorder 10)Histroy of other active malignancy 11)Pregnancy, the desire to preserve 12)Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events,PFS,MST,TTP | — |
Countries
Japan
Contacts
Public ContactNorisuke Nakayama
Kanagawa Cancer Center Division of Gastroenterology
Outcome results
None listed