Randomized phase II trial of neoadjuvant Chemotherapy with Gemcitabine and S-1 vs. without neoadjuvant chemotherapy in patients with resectable pancreatic cancer
- Conditions
- Resectable pancreatic cancer
- Registration Number
- JPRN-UMIN000009822
- Lead Sponsor
- Chiba study group of adjuvant chemotherapy for pancreatic cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
Not provided
1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction 2. Sever myelosuppression 3. Pregnancy, breast feeding, or women who desire to preserve fecundity 4. Sever renal dysfunction 5. Sever hepatic dysfunction 6. With other anticancer treatment 7. With flucitocine or warfarin potassium treatment 8. With pulmonary fibrosis 9. With history of radiation to lung field 10. Active infectious disease 11. Massive pleural effusion 12. With distant metastasis 13. Active malignancies other than pancreatic cancer 14. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure 15. Severe diabetes or hypertension 16. Severe mental disorder 17. Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two year disease progression free survival rate
- Secondary Outcome Measures
Name Time Method overall survival, disease free survival, R0 resection rate, R0+1 resection rate, histological efficacy of chemotherapy, Adverse events, recurrent location, tumor marker level, relative intensity, surgical complication rate, responce rate