pancreatic cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Histologically, radiologically or serologically diagnosed pancreatic adenocarcinoma (2) Borderline resectable or unresectable pancreatic cancer with measurable lesion (3) No prior treatment for pancreatic cancer (4) Age of 20 and more (5) ECOG performance status of 0 or 1 (6) Adequate hematologic, hepatic, renal and respiratory function (7) Orally feedable (8) Clinically normal electrocardiogram (9) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Resectable pancreatic cancer (2) Presence or past history of Interstitial pneumonia or pulmonary fibrosis or possible (3) Watery diarrhea (4) Active infections (excluding viral hepatitis) (5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus (6) Presence of pleural effusion or ascites requiring drainage (7) Presence of metastasis in central nervous system (8) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 years) (9) Treatment with phenytoin, potassium warfarin or flucytosine (10) Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period. (11) Severe mental disorder (12) Severe drug hypersensitivity (13) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, overall survival (OS), relapse free survival (RFS), progression free survival (PFS), feasibility, curative resection rate | — |
Countries
Japan
Contacts
Osaka University Gastroenterological Surgery