NIPH Clinical Trials Search

UMIN ID: UMIN000002176

Registered date:01/08/2009

A clinical phase-II trial of neoadjuvant chemoradiation therapy using S-1 for locally advanced pancreatic cancer (PerSeUS-GP-01)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedLocally advanced pancreatic cancer
Date of first enrollment2009/08/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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; 80mg/m2 administration for 14 days, followed by a resting period for 7 days.


Primary Outcome1-year survival rate
Secondary Outcomeprogression free survival, surgical resection rate, curative resection rate, effective rate and complication rate of the neoadjuvant chemoradiation therapy, 5-year survival rate

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. 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.

Related Information


public contact
Name Ichiro Yasuda
Address 1-1 Yanagido, Gifu 501-1194, Japan Japan
Affiliation Gifu University Dept. of Gastroenterology
scientific contact
Name Hisataka Moriwaki
Address 1-1 Yanagido, Gifu 501-1194, Japan Japan
Telephone 058-230-6308
Affiliation Gifu University Dept. of Gastroenterology