pancreatic cancer
Conditions
Interventions
Concurrent radiotherapy with S-1: S-1(80mg/m2) on the irradiated day, Radiotherapy
a total dose of 50.4 Gy in 28 fractions. S-1+gemcitabine: Gemcitabine(1000mg/m2) is given by intravenous infusion over 30 min on days 1, 8. S-1(80mg/m2) is given orally for 14 days followed by 1-wee
Sponsors
Department of Surgical Oncology and Gastroenterological Surgery, Sapporo Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically or cytologically or diagnostic imaging proven diagnosis of pancreatic cancer 2) Definition of a Borderline respectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma 3) Patients of age =>20 and 75=> 4) Performance Status: 0-1(ECOG) 5) Patients who have not undergone chemotherapy and/or radiotherapy 6) All pancreas lesions and lymphnode metastases are included in the radiation field, 10 x 10 cm 7) Adequate oral intake 8) Biliary drainage was applied adequately in patients with obstructive jaundice 9) Without obvious direct invasion to digestive tract 10) Sufficient organ functions 14 days before registration 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have previously administered S-1 or gemcitabine 2) Patients who have previous history of radiotherapy to the abdomen 3) Uncontrollable watery or chornic diarrhea 4) Regular use of frucitocin, fenitoin or warfarin 5) Patients who can' t receive neither iodic drug because of drug allergy 6) Lung fibrosis or interstitial pneumonia which accompanied by clinical symptoms or are evident in imaging findings 7) Massive pleural or abdominal effusion 8) Those with Active infectious diseases 9) Uncontrolled diabetes 10) Simultaneous or metachronous (within 3 years) double cancers 11) Hemorrhagic peptic ulcer 12) Severe complications 13) Patients requiring systemic steroids medication 14) Severe mental disorders 15) Severe drug hypersensitivity 16) Pregnant or lactating women, or women with known or suspected pregnancy and men who want let to pregnancy 17) Patients seems inadequate for this study by investigators 18) Treatment history of a collagen disease or undergoing medical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate , pathological response rate , survival rate, Response rate, adverse effect | — |
Countries
Japan
Outcome results
None listed