advanced pancreatic cancer
Conditions
Interventions
L-OHP: fixed dose IRI: dose escalation S-1: fixed dose
Sponsors
KANAPS(Kansai and Nara Pancreatobiliary Study group)
Eligibility
Sex/Gender
All
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) 7) Active double cancer 8) Pregnancy 9)Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phase I study: Safety,Frequency of DLTs phase II study: response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, and adverse events | — |
Countries
Japan
Contacts
Public ContactTomohisa Yamamoto
Kansai Medical University Surgery Division
Outcome results
None listed