Resected pancreatic cancer
Conditions
Interventions
S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated until 6 months or to meet discontinuation criteria.
S-1 40 mg/m2 is given orally twice a d
Sponsors
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with written informed consent 2) Patients who are judged to be suitable for receiving this protocol therapy by the physician 3) Resected cases with histologically proven invasive ductal carcinoma of the pancreas 4) According to the UICC 7th classification; - Stage I or II, or III in whom celiac artery resection was performed - R0 or R1 - Cancer negative for washing cytology of the abdominal cavity 5) No distant metastasis nor malignant ascites 6) Adequate oral intakes 7) Aged 20 years and older 8) An Eastern Cooperative Oncology Group performance status of 0 or 1 9) No prior history of chemotherapy nor radiation therapy within three years 10) Within 10 weeks after operation 11) Sufficient organ function of bone marrow, liver, and kidney: 12) Patients with laboratory data within 14days before enrollment as follows; Leukocytes >= 3,000 /mm3 and <= 12,000 /mm3, Platelets >= 100,000 /mm3, Hemoglobin >= 8.0 g/dL, Serum total bilirubin <= 2.0 mg/dL, Serum aspartate aminotransferase (AST) <= 100 IU/L, Serum alanine aminotransferase (ALT) <= 100 IU/L, and Serum creatinine <= 1.2 mg/dL
Exclusion criteria
Exclusion criteria: 1) Previously treated by chemotherapy for locally advanced pancreatic cancer 2) Prior history of S-1 therapy 3) History of serious drug hypersensitivity or a history of drug allergy 4) Patients with contraindication for the medication of S-1 5) Serious complications ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, intractable diabetes, intractable hypertension) 6) Recurrent disease before enrollment 7) Moderate or ascites or pleural effusion 8) Plumonary fibrosis or interstitial pneumonia diagnosed by chest X-ray. 9) Serious diarrhea 10) Myocardial infarction within six months 11) Active infection(fever up; over 38 degree) 12) Blood transfusion within 2 weeks before enrollment 13) Severe mental disorder 14) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free survival of 5 years or less). 15) Pregnant or lactating woman and man who hope for partner&#39;s pregnancy 16) Patients who need flucytosine, phenytoin or warfarin potassium. 17) Requiring continous steroid administration 18) Not appropriate for the study at the physician&#39;s assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS, OS, Dose Intensity, Complete rate of each treatment point (3 and 6, 9, 12 months), Safety | — |
Countries
Japan
Contacts
Public ContactNorifumi HARIMOTO
Graduate School of Medical Sciences, Kyushu University Department of Surgery and Science
Outcome results
None listed