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