advanced gastric cancer
Conditions
Interventions
TS-1+CDDP+Lentinan TS-1:80-120mg/day for 3weeks,followed by 2weeks rest period 35st 1 course. CDDP:60mg/m2 on day 8 each course. Lentinan:2mg/body/week on 1,8,15 day each course.
Sponsors
Chiba University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Confirmed adenocarcinoma 2)Evaluable lesion by RECIST version1.11 within 28 days 3)No previous treatment 4)Adequate organ fanction 5)PS(ECOG):0-2 6)Prognostic period >= 3 months from enrollment 7)20>=,<80 years old 8)Oral intakes is possible 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Serious drug hypersesitivity 2)Active infection 3)Clitical condition of heart disease 4)Serious coexisting illness diabetes mellitus,uncontrolled or controlled with insulin,liver cirrhosis,renal disfunction,severe pulmonary dysfunction,bowel dysfunction,history of myocardial infarction 5)Massive hydrothorax or ascites 6)Multiple bone metastases 7)Brain metastasis 8)Active bleeding of digestive tract 9)Diarrhea 10)Severe mental disorders 11)Have other cancers than gastric cancer 12)Pregnant or nursing 13)Pregnant or nursing 14)Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| feasibility,PFS,OS,TTF,RR,Clinical benefit rate(CBR),G/L,QOL | — |
Countries
Japan
Contacts
Public ContactMikito Mori
Chiba graduate school of medicine Department of frontier surgery
Outcome results
None listed