Unresectable pancreatic cancer
Conditions
Interventions
Patients receive arterial infusion of 5-FU via an indwelling catheter and port system and systemic GEM at day 1,8, and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progr
Sponsors
Nara Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)confirmention of pathologicaly proven invasive pancreatic ductal cancer (adenocarcinoma) 2)Unresectable because of locally advanced pancreatic lesion and/or liver metastases 3)Measurable lesion in the live and/or pancreas according to RECIST 4)malignant lesion in other organ 5)no prior treatment except for surgery 6)PS=0-1(Eastern Cooperative Oncology Group (ECOG) performance ) 7)adequate hepatic, renal, bone marrow function Expected survival more than 8 weeks. WBC count>=3,000/L ANC >=1500/L platelet count>=100,000/L Hb >=9.0mg/dl T-bil <=3.0mg/dl AST/ALP <=5times the upper nomal limits Cre <=1.5mg/dl 8)written informed concent
Exclusion criteria
Exclusion criteria: 1)distant metastaes except of liver and node 2)adequate drug distribution via celiac arterial infusion with alteration of pancreatic blood flow will not be achieved 3)Interstitial pneumonia in chest X-ray 4)active gastro-duodenal ulcer 5)Allergic reaction to iodine contrast material. 6)Infectious disease with fever over 38 degree Celcius or antibiotics required. 7)Pregnant or nursing. 8)Severe drug allergic reaction 9)The other severe complicated disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, progression-free survival and over all surval | — |
Countries
Japan
Contacts
Public ContactToshihiro Tanaka
Nara Medical University Dept of radiology
Outcome results
None listed