Unresectable pancreatic cancer
Conditions
Interventions
Discontinuation of Pegfilgrastim
Sponsors
Kanazawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma 2)Receiving >=2cycles of FOLFIRINOX with pegfilgrastim and no findings of FN 3)Age >=20, <75 4)ECOG Performance Status 0-1 5)Life expectancy >=12weeks 6)Meets the following criteria within 7days before enrollment 1. absolute neutrophil: >=2,000/mm3 2. platelet count: >=100,000/mm3 3. total bilirubin: =<2.0 mg/dL 7)No progressive radiological findings within 14days before enrollment. 8)Tumor is regarded as unresectable. 9)With appropriate drainage for obstructive jaundice 10)Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)Severe myelosuppression 2)Active infection (except viral hepatitis) 3)Serious complications (organ failure, or active peptic ulcer etc) 4)Severe diarrhea 5)Intestinal pneumonitis or pulmonary fibrosis 6)Treatment-resistant ascites or pleural effusion 7)Brain or meningeal metastasis 8)Pregnancy or breast-feeding 9)Any contraindication for FOLFIRINOX 10)Severe complication by administration of pegfilgrastim 11)Severe mental disorder, or central nervous system disorders 12)Contraindication for dynamic CT/MRI 13)Inappropriate for this study judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of febrile neutropenia during the first 2 cycles of FOLFIRINOX | — |
Countries
Japan
Contacts
Public ContactTakeshi Terashima
Kanazawa University Hospital Department of Gastroenterology
Outcome results
None listed