pancreatic cancer
Conditions
Interventions
S-1 is administered orally twice daily after morning and evening meals at a dose of 80-150 mg/day on Mondays, Wednesdays, Fridays and Sundays. The study treatment is repeated for 24 weeks.
Sponsors
Fukushima Medical University Hospital, School of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Resected cases with histologically proven invasive ductal carcinoma of the pancreas 2) According to the UICC classification, a) Stage I, II, or III b) R0 or R1 3) No distant metastasis 4) No prior history of chemotherapy nor radiation therapy for pancreatic cancer 5) Age of 20 years or older 6) An Eastern Cooperative Oncology Group performance status of 0 or 1 7) Sufficient organ function: Neutrophil count >= 1,500 /mm3 Platelet count >= 100,000 /mm3 Hemoglobin >= 9.0 g/dL Serum total bilirubin <= 2.0 mg/dL, AST <= 150 IU/L ALT <= 150 IU/L Serum creatinine <= 1.2 mg/dL Creatinine clearance >= 50 mL/min 8) Within 10 weeks after surgery 9) Adequate oral intakes 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Contraindication of S-1 2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration 3)Pulmonary fibrosis or interstitial pneumonia 4)Watery diarrhea 5)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis 6)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). 7)Moderate or severe (requiring drainage) ascites or pleural effusion 8) Current use of flucytosine 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 10) Severe mental disorder. 11) Severe drug allergies. 12) Positive HBs antigen and/or HCV antibody. 13)Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Relapse-free Survival Incidence and Severity of Adverse Events | — |
Countries
Japan
Contacts
Public ContactTatsuo Shimura
Fukushima Medical University Hospital, School of medicine Department of Organ Regulatory Surgery
Outcome results
None listed