untreated advanced or recurrent gastric cancer
Conditions
Interventions
Cisplatin, Day1 Level 0: 30mg/m2 Level 1: 40mg/m2 Level 2: 50mg/m2 Level 3: 60mg/m2 S-1 (80mg/m2), Day1-14, 22-35 Docetaxel (40mg/m2), Day22 Repeat every 6 weeks
Sponsors
Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed adenocarcinoma of the stomach 2) Unresectable disease 3) Sufficient oral intake 4) Measurable lesion(s) defined by RECIST 5) No prior chemotherapy, radiotherapy for advanced cancer 6) Age of 20-74 years 7) ECOG performance status of 0 to 2 8) Expected survival more than 3 months 9) Adequate organ function 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active other malignancy 2) Interstitial pneumonitis, pulmonary fibrosis 3) Massive pleural effusion or massive ascites 4) Active infection 5) Watery diarrhea 6) Other uncontrolled severe illness 7) Brain metastases 8) Pregnant or lactating women 9) Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Maximum Tolerated Dose, Recommended dose Phase II: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Progression free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactAyumu Hosokawa
University of Toyama Department of Gastroenterology and Hematology, Faculty of Medicine
Outcome results
None listed