Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II
- Conditions
- nresectable locally advanced pancreatic cancer
- Registration Number
- JPRN-UMIN000014039
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Not provided
1)Severe drug hypersensitivity 2)Severe dysesthesia with functional disorder 3)homozygote(UGT1A1 *6/*6, UGT1A1 *28/*28) or heterozygote(UGT1A1 *6/*28) 4)Prior treatment(chemotherapy or radiation) 5)Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 5 year) except carcinoma in situ or intramucosal cancer 6)Infections that needs systemic treatment. 7)Pregnant females or being suspected, or nursing mothers. 8)Severe nervous disorder or mental disorder. 9)Transufusion, Blood products and G-CSF tried within 7days before enrollment. 10)Much pleural effusion, ascites fluid, pericardial fluid. 11)Jaundice 12)Congestive heart failure, symptomatic cerebrovascular accident, uncontrolable arrhythmia, and history of myocardial infarction in 12 months 13)Severe interstitial pneumonia or pulmonary fibrosis. 14)Diarrhea(to bring troubles in patients who have stoma) 15)Active peptic ulcer, paresis of intestine and ileus 16)Uncontrolled diabetes mellitus(DM) or DM with nervous disorder. 17)Need continuous medication of atazanavir sulfate. The subject who was determined by investigator that being not adequate to participate in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the ratio of R0 resection
- Secondary Outcome Measures
Name Time Method the ratio of R0+R1 resection, Response rate, Progression Free Survival: PFS, Overall Survival: OS, Safety