Overview

Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wakayama Medical University
Treatments:
Irinotecan
Oxaliplatin
Criteria
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