Multicenter phase I/II trial of adjuvant combination chemotherapy with gemcitabine and S-1 for pancreatic cancer
Phase 1
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-UMIN000001038
- Lead Sponsor
- Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1)Watery diarrhea 2)Severe mental disorder 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Symptomatic pulmonary fibrosis or interstitial pneumonia 6)History of radiation therapy to the chest 7)Marked pleural or peritoneal effusion 8)Active concomitant malignancy 9)Treatment with phenytoin, potassium warfarin or flucytosine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: the maximum-tolerated dose and dose-limiting toxicity of GS therapy. Phase II: overall survival.
- Secondary Outcome Measures
Name Time Method Phase II: adverse events and disease-free survival.