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

UMIN ID: UMIN000002176

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Locally advanced pancreatic cancer
• Date of first enrollment: 2009/08/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: 1-year survival rate
• Secondary Outcome: progression 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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: PerSeUS-GP
• Secondary Sponsor: Gifu Prefectural Medical Center Gifu Municipal Hospital
• Source(s) of Monetary Support: none