Metastatic or locally advanced pancreatic cancer
Conditions
Interventions
Sponsors
Pancreatic Cancer Treatment Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed pancreatic cancer as adenocarcinoma or adenosquamous carcinoma 2)Non-resectable and confirmed target region 3)No prior treatment 4)Age 20-79 5)PS 0/1 6)Adequate organ functions neutrophils >=2,000/mm3 leukocytes >=3,500/mm3 platelets >=100,000/mm3 hemoglobin >=9.0g/dL AST(GOT)/ALT(GPT) <=150IU/L total bilirubin <=2.0mg/dL serum creatinine <=1.2mg/dL creatinine clearance >=60mL/min 7)Sufficient oral intake 8)Normal ECG 9)Written informed concent
Exclusion criteria
Exclusion criteria: 1)Symptomatic pulmonary fibrosis or interstitial pneumonia 2)Severe diarrhea 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Marked pleural or peritoneal effusion 6)Metastasis in central nervous system 7)Active double cancer 8)Patients under treatment with flucytosine, phenytoin or warfarin potassium 9)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 10)Severe mental disorder 11)History of severe anaphylaxies 12)Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure, Disease Control Rate, Adverse Events, Administration Rate of S-1 | — |
Countries
Japan
Outcome results
None listed