Incasive ductal carcinoma of pancreas with macroscopic complete resection
Conditions
Interventions
Gemcitabine adjuvant chemotherapy: Three weekly infusions of gemcitabine at 1000mg/m2 followed by 1week pause as 1 course. total 12 courses
S-1 adjuvant chemotherapy: S-1 80mg/m2/day for 14days fol
Sponsors
Chiba study group of adjuvant chemotherapy for pancreatic cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who had pancratic cancer histologically verified as invasive ductal carcinoma and who had undergone macroscopic complete resection. 2. Being aged 20 years or older and 79 years or younger at the time of registration. 3. Without prior radiation or chemotherapy. 4. With performans status 0-2 level. 5. Adequate hematologic, renal and hepatologic function WBC => 4000/mm3 neutrophil => 2000/mm3 Platelet => 100000/mm3 Hemoglobin => 9.0 g/dl AST, ALT <= ULN X 2.5 Total bilirubin < 3.0 mg/dl Creatinine <= ULN 6. Provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction 2. With pulmonary fibrosis or interstitial pneumonia 3. Massive pleural effusion 4. With distant metastasis 5. Active malignancies other than pancreatic cancer 6. Active infectious disease 7. Severe post operative complications 8. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure 9. Severe diabetes or hypertension 10. Severe mental disorder 11. Pregnancy, breast feeding, or women who desire to preserve fecundity 12. Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two year disease-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, toxicity, completion rate | — |
Countries
Japan
Contacts
Public ContactHideyuki Yoshitomi
Chiba unviersity, Graduate School of Medicine General Surgery
Outcome results
None listed