unresectable pancreatic cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed invasive ductal carcinoma 2) Unresectable locally advanced, metastatic, or recurrent disease 3) No prior chemotherapy or radiotherapy for pancreatic cancer 4) Aged 20 to 75 years old 5) ECOG PS of 0 or 1 6) Adequate organ functions 7) Sufficient oral intake 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Grade 2 or greater peripheral neuropathy 2) Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene 3) Moderate ascites 4)Intestinal pneumonitis or pulmonary fibrosis 5) Uncontrollable diarrhea 6) Serious complications (organ failure, uncontrolled diabetes mellitus, active infection, ulcer, ileus, mental disorders, or central nervous system disorders) 8) Active double cancer 9) Pregnancy 10)Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of DLT (Dose Limiting Toxicity) , determination of MTD (Maximum Tolerated Dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| the frequency of side effect, response rate, progression-free survival, overall survival | — |
Countries
Japan
Contacts
Hokkaido University Hospital Gastroenterology and Hepatology