Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study
Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents
 a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of
 the high response rate treatment regimen , the investigators considered as a promising
 treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4
 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX
 group compared with gemcitabine group. Therefore, it was decided to consider the balance of
 safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen
 by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from
 FOLFIRINOX regimen
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents
 a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of
 the high response rate treatment regimen , the investigators considered as a promising
 treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4
 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX
 group compared with gemcitabine group. Therefore, it was decided to consider the balance of
 safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen
 by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from
 FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX
 therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0
 resection rate, and resection rate for borderline resectable pancreatic cancer.
Inclusion Criteria:

 -  Pathologically proven invasive pancreatic ductal carcinoma

 -  Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

 1. Definition of a borderline resectable pancreatic cancer is filledin NCCN
 guideline version 1.2014 pancreatic adenocarcinoma

 2. Patients indicated distal pancreatectomy with en bloc celiac axis resection

 -  PS (ECOG) 0-1

 -  ≧20 years old and < 75 years old

 -  First line treatment

 -  The following criteria must be satisfied in laboratory tests within 14 days of
 registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet
 count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of
 normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL

 -  Written informed consent to participate in this study

 Exclusion Criteria:

 -  Severe drug hypersensitivity

 -  Multiple primary cancers within 5 years

 -  Severe infection

 -  With grade2 or more severe peripheral neuropathy

 -  With intestinal paralysys, ileus

 -  Interstitial pneumonia or pulmonary

 -  With uncontrollable pleural effusion or ascites

 -  Receiving atazanavir sulfate

 -  With uncontrollable diabetes

 -  With uncontrollable heart failure, angina, hypertension, arrhythmia

 -  With severe psychological symptoms

 -  With watery diarrhea

 -  Pregnant or lactating women, or women with known or suspected pregnancy

 -  Inappropriate patients for entry on this study in the judgment of the investigator

 -  With UGT1A1*28 and/or UGT1A1*6 polymorphisms