Resected pancreatic cancer
Conditions
Interventions
S-1by Alternate day administration for 180days (6months) (1 course=6weeks, 42days).
S-1 for 28 days with 14 days rest for 180days (6months) (1 course=6weeks, 42days).
Sponsors
HORE
iwata city hospital Hamamatsu medical center shizuoka city shimizu hospital
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 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 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior history of S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) Severe infection 7) Blood transfusion within two weeks 8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 9) Severe mental disorder 10) Severe drug allergy 11) Other active malignancy 12) Pregnancy, breast feeding, or women who desire to preserve fecundity or Men who desire to have children 13) Regular use of frucitocin, fenitoin or warfarin 14) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment complete rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival, overall survival, Safety | — |
Countries
Japan
Contacts
Public ContactTakanori Sakaguchi
Hamamatsu University School of Medicine Second Department of Surgery
Outcome results
None listed