PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
- Conditions
- locally advanced pancreatic cancer
- Registration Number
- JPRN-UMIN000013385
- Lead Sponsor
- Osaka Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1)with pulmonary fibrosis or interstital pneumonia which can be detected from X-ray incontrovertibly or has clinical symptom 2)with severe diarrhea within 3 days before entry 3)with other severe diseases(heart failure, renal disfunction, liver disfunction, intestinal paralysys, ileus, uncontrolled DM) 4)patients whom administered flucitosine or Fenitoin or Warfarin 5)with active double cancers whose disease free period is shorter than 5 years Carcinoma in situ can be excluded. 6)with infectious disease which needs therapy 7)with body temperature over 38 degrees Celsius 8)women who are pregnant or expect to be pregnant, or nursing female 9)patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 10)general administration of steroids 11)with grade 2 or more severe peripheral neuropathy 12)with UGT1A1*28 and/or UGT1A1*6 polymorphisms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 year survival rate
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS), Overall survival (OS), Response Rate (RR), Incidence of adverse events, Incidence of grade 3/4 adverse events, R0 resection rate