A clinical phase-II trial of neoadjuvant chemoradiotherapy with S-1 and Gemcitabine for locally advanced pancreatic cancer (PerSeUS-GP02)

A clinical phase-II trial of neoadjuvant chemoradiotherapy with S-1 and Gemcitabine for locally advanced pancreatic cancer (PerSeUS-GP02) - PerSeUS-GP02

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010435

Enrollment

Registered

2013-04-06

Start date

2013-04-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced pancreatic cancer

Interventions

After chemoradiation therapy with S-1 and Gemcitabine, surgical resection is carried out. Post operative chemotherapy with S-1 is continued for 1 year. S-1

80mg/m2/day (administration on the day of radiation therapy) Gemcitabine

1000mg/m2/day, day1, 15, 29 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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically, cytologically or radiographically proven pancreatic cancer 2. Stage IVa borderline resectable pancreatic cancer defined in NCCN guidelines 2012 pancreatic adenocarcinoma 3. At least one measurable lesion 4. No prior history of the treatment such as surgical operation, radiotherapy, and chemotherapy for the lesion 5. ECOG performance status of 0-1. 6. Adequate oral intakes 7. Sufficient organ function: Leukocytes: >= 3,500/mm3 Neutrophil: >= 2,000/mm3 Platelets: >= 100,000/mm3 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. Pregnancy, breast feeding, or women who desire to preserve fecundity. Men who want his partner to be pregnant. 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 Response rate Safety	—

Countries

Japan

Contacts

Public ContactIchiro Yasuda

Gifu University graduate school of medicine Department of Gastroenterology

058-230-6308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026