Locally advanced pancreatic cancer
Conditions
Interventions
Surgical resection after chemoradiation therapy. S-1 administration after the surgical resection. Radiation therapy concurrently with S-1: S-1
80mg/m2/day (administration on the day of radiation therapy) Radiation therapy
a total dose of 39.6Gy by 22 fractions. Post operative chemotherapy with S-1: S-1
Sponsors
PerSeUS-GP
Gifu Prefectural Medical Center Gifu Municipal Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria : 1. Pancreatic cancer whose diagnosis was confirmed by pathological or imaging results. 2. Possibly resectable locally advanced pancreatic cancer, fulfilled at least one of the following criteria on CT findings: 1) Retroperitoneal invasion (RP): Shaggy sign of peripancreatic tissue is presented. 2) Direct invasion to the portal system (PV): Tumor causes deformity of the PV, but contacts it less than 1/4 circle, or no deformity but contacts more than 1/4 circle. 3)Direct invasion to the arteries (A): Tumor causes no deformity, and contacts them less than 1/4 circle. Not fulfilled any of the following criteria on CT findings: 4)Retroperitoneal invasion (RP): Tumor invades definitively to the inferior vena cava or aorta. 5)Direct invasion to the portal system (PV): Tumor causes severe stenosis or obstruction of the PV. 6)Invasion to the arteries (A): Tumor causes deformity or contacts them more than 1/4 circle. 3. presence of measurable lesions. 4. without prior history of the treatment such as surgical operation, radiotherapy, and chemotherapy for the lesion. 5. ECOG performance status : 0-1. 6. Normal oral intake. 7. Sufficient organ function: Leukocytes: >= 3,500/mm2 Neutrophil: >= 2,000/mm2 Platelets: >= 100,000/mm2 Hemoglobin: >= 9g/dL Serum total bilirubin: <= 2.0mg/dL (or 3.0mg/dL in cases after biliary drainage) Serum transaminases: AST <= 100U/L (or 150U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases after biliary drainage) Serum creatinine: <= 1.2mg/dL Creatinine clearance: >= 50ml/min (option) 8. Life expectancy of more than 3 months. 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Lung fibrosis or interstitial pneumonia. (should be confirmed by chest radiograph or CT within 28 days before the entry) 2. Watery diarrhea or chronic diarrhea 3. Regular use of Fenitoin, Warfarin or Frucitocin. 4. Pleural effusion or ascites. 5. Active infection. 6. Other malignancies. 7. Active gastroduodenal ulcer. 8. Serious comorbid illness. (heart failure, renal failure, liver failure, intestinal paralysis, uncontrolled diabetes, etc) 9. Serious mental disorder. 10. Serious drug allergy. 11. During pregnancy or lactation. 12. Patients who were judged inappropriate for the entry to this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, surgical resection rate, curative resection rate, effective rate and complication rate of the neoadjuvant chemoradiation therapy, 5-year survival rate | — |
Countries
Japan
Contacts
Public ContactIchiro Yasuda
Gifu University Dept. of Gastroenterology
Outcome results
None listed