Resected pancreatic cancer
Conditions
Interventions
Gemcitabine 1000 mg/m2 is given by intravenous infusion over 30 minutes on days 1, 8, and 15, followed by a 1-week pause. This cycle is repeated for six months or until recurrent disease is confirmed.
Sponsors
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible criteria are as follows: 1) Resected cases with histologically proven invasive ductal carcinoma of the pancreas 2) According to the UICC classification, a) Stage I or II, or III in whom celiac artery resection was performed b) R0 or R1 c) Cancer negative for washing cytology of the abdominal cavity 3) No distant metastasis nor malignant ascites 4) Adequate oral intakes 5) Aged 20 years or older 6) An Eastern Cooperative Oncology Group performance status of 0 or 1 7) No prior history of chemotherapy nor radiation therapy within three years 8) Within 10 weeks after operation 9) Sufficient organ function: 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 10) Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria are as folllows: 1) Prior history of gemcitabine therapy or S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) NYHA III or IV cardiac function 7) Myocardial infarction within six months 8) Severe infection 9) Severe diabetes 10) Blood transfusion within two weeks 11) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 12) Severe mental disorder 13) Severe drug allergy 14) Other active malignancy 15) Pregnancy, breast feeding, or women who desire to preserve fecundity 16) Men who desire to have children 17) Regular use of frucitocin, fenitoin or warfarin 18) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events Relapse-free survival Health-related quality of life | — |
Countries
Japan
Contacts
Public ContactKatsuhiko Uesaka
Shizuoka Cancer Center Hospital Division of Hepato-Biliary-Pancreatic Surgery
Outcome results
None listed