locally advanced pancreatic cancer
Conditions
Interventions
85mg/m2 administration on day1, LV
400mg/m2 administration on day1, CPT-11
180mg/m2 administration on day1, 5-FU bolus
400mg/m2 administration on day1, 5-FU 46h infusion
2400mg/m2 administration on day1 46hour One course lasts 2 weeks (14 days)
Sponsors
Osaka Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma; papillary, tubular, poorly, adenosquamous. There is no distant metastasis. 2)Unresectable locally advanced pancreatic cancer(a definition; NCCN guide line Version 1.2014) 3)Age under 75 4)PS(ECOG) between 0 and 1 5)No previous surgical resection, radiation and chemotherapy for pancreatic cancer 6)No previous therapy for other cancer within 5 years(exept for endoscopic surgery) 7)with a good condition of important organs within 14 days of registration 1. neutrophil>=1,500/mm3 2. hemoglobin>=9.0g/dL 3. platelet>=100,000/mm3 4. Albumin>=3.0g/dL 5. total bilirubin<=upper limits of normal(ULN) 6. AST<=2.5 x ULN 7. AST<=2.5 x ULN 8. serum creatinine<=1.2mg/dL 8)written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS), Overall survival (OS), Response Rate (RR), Incidence of adverse events, Incidence of grade 3/4 adverse events, R0 resection rate | — |
Countries
Japan
Contacts
Public ContactMasahiro Goto
Osaka Medical College Hospital Cancer Chemotherapy Center
Outcome results
None listed