Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer
Phase 2
Recruiting
- Conditions
- Resected pancreatic cancer
- Registration Number
- JPRN-UMIN000010922
- Lead Sponsor
- HORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1) Prior history of S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) Severe infection 7) Blood transfusion within two weeks 8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 9) Severe mental disorder 10) Severe drug allergy 11) Other active malignancy 12) Pregnancy, breast feeding, or women who desire to preserve fecundity or Men who desire to have children 13) Regular use of frucitocin, fenitoin or warfarin 14) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method treatment complete rate
- Secondary Outcome Measures
Name Time Method Relapse free survival, overall survival, Safety