StageIV gastric cancer
Conditions
Interventions
Selection of chemotherapy 1)S-1 is administered orally at the dose of 80 mg/m2/day b.i.d. for 14 days, followed by 7 days of rest. Docetaxel is administered i.v. at the dose of 40 mg/m2 on day 1. Re
Sponsors
PerSeUS-GC
Gifu Municipal Hospital Gifu Prefectural Medical Center Hiroshima University Kanazawa Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed gastric carcinoma 2)Advanced StageIV gastric cancer 3)Age of 20 years or older 4)No history of gastrectomy 5)No prior radiotherapy and chemotherapy 6)Measurable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST) 7)No brain metastasis 8)ECOG PS 0 to 1 9)S-1/docetaxel or S-1/cisplatin combination therapy is possible 10)Expected survival over 3 months 11)Adequate organ functions 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of severe hypersensitivity (allergy) to any medicines 2)Administration contraindication of S-1 and combination agent 3)Continuous use of flucytosine, phenytoin or warfarin potassium 4)Active infection 5)Severe complications, such as intestinal paralysis, ileus, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure 6)Watery stools or diarrhea 7)Massive pleural or abdominal effusion 8)Active double cancer 9)Pregnant or nursing females. 10)Males who are planning partners' pregnancy. 11)Not suitable for participation with any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative complications | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression-free survival, histological response, resection rate, response rate | — |
Countries
Japan
Contacts
Public ContactYAMAGUCHI, Kazuya
Gifu University, Graduate School of Medicine Department of Surgical Oncology
Outcome results
None listed