Pancreatic cancer
Conditions
Interventions
a combination therapy with gemcitabine, S-1 and leucovorin
Sponsors
The University of Tokyo, Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with unresectable pancreatic cancer without prior treatment 2) Patients with pathologically proven pancreatic cancer 3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 4) Patients of age >= 20 years 5) Patients who can eat 6) Patients have an adequate organ function defined as white cell count < 10,000/mm3, neutophils >=1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal 7) Estimated survival > 2months 8) Written informed consent is required from all patients.
Exclusion criteria
Exclusion criteria: 1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diarrhea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 9) Inappropriate patients for entry on this study in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity, maximum tolerated dose, recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, disease control rate, progression free survival, overall survival, 1-year survival rate, feasibility, safety | — |
Countries
Japan
Contacts
Public ContactYousuke Nakai
University of Tokyo Gastroenterology
Outcome results
None listed