HER2 positive gastric cancer
Conditions
Interventions
Chemotherapy for gastric cancer
Sponsors
Nagoya City University Hospital, Department of gastroenterology
Japan Red Cross Nagoya Daini Hospital, Nagoya City East Medical Center, Nagoya City West Medical Center, Toyokawa Municipal Hospital, Gifu Prefectural Tajimi Hospital, Chukyo Hospital, Kasugai Municipal Hospital, Gamagoori Municipal Hospital, Aichi Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.case which was diagnosed as gastric cacner by histopathologically. 2. unresectable gastric cancer 3. HER2 positive (IHC 3+ or IHC 2+ and FISH positive) 4. age 20-80 Y 5. ECOG PS:0-2 6. case which has lesions to be evaluated 7. patient who is possible of ingestion 8. initial treatment case (patient who had adjuvant chemotherapy by TS-1 more than 24 weeks ago) 9. patient who is expected to be survival more than 3 months 10. LVEF>50% by UCG 11. WBC:3,000 / mm3-12,000 / mm3 Neutro:>1,500/mm3 Plt:>100,000/mm3 Hb:>9.0 g/dl AST(GOT),ALT(GPT):<100 IU / l T-Bil:<2.0mg / dl C.Cr:>60ml / min (Cockcroft- Gault) 12. patient who was taken IC by document
Exclusion criteria
Exclusion criteria: 1.patient who has drug allergy as past history 2. case of administration contraindication 3. patient who needs flucytosine, phenytoin, and Warfarin 4. patient who has active infectious disease with fever over 38 degree 5. patient who has severe complication (intestinal palsy, ileus, interstitial pneumonia, DM, renal failure, liver failure under bad control) 6. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 7. patient who has metastatic brain tumor with symptoms 8. watery diarrhea 9. severe ascites and/or pleural effusion 10. patient who has active double cancer 11. patient who want to be pregnant and /or pregnant woman 12. man who want to have a child 13. patient who was not judged to be suitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, PFS, RR, molecular marker expression analysis, | — |
Countries
Japan
Contacts
Public ContactHiromi Kataoka
Nagoya City University Hospital, Department of gastroenterology Nagoya City University Hospital, Department of gastroenterology
Outcome results
None listed