A randomized phase II trial of adjuvant Chemotherapy with Gemcitabine alone, S-1 alone, versus gemcitabine and S-1 in patients with resected pancreatic cancer
Phase 2
- Conditions
- Incasive ductal carcinoma of pancreas with macroscopic complete resection
- Registration Number
- JPRN-UMIN000002000
- Lead Sponsor
- Chiba study group of adjuvant chemotherapy for pancreatic cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
Not provided
Exclusion Criteria
1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction 2. With pulmonary fibrosis or interstitial pneumonia 3. Massive pleural effusion 4. With distant metastasis 5. Active malignancies other than pancreatic cancer 6. Active infectious disease 7. Severe post operative complications 8. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure 9. Severe diabetes or hypertension 10. Severe mental disorder 11. Pregnancy, breast feeding, or women who desire to preserve fecundity 12. 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-free survival rate
- Secondary Outcome Measures
Name Time Method overall survival, toxicity, completion rate