Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

Wakayama Medical University10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (9)

Nagoya University

Nagoya, Aichi-ken, Japan

Kobe University

Kobe, Hyōgo, Japan

Nara Prefectual Medical University

Kashihara, Nara, Japan

Kansai Medical University

Hirakata, Osaka, Japan

Osaka University

Suita, Osaka, Japan

Hiroshima University

Hiroshima, Japan

Osaka City University

Osaka, Japan

Osaka Medical Center for Cancer and CVD

Osaka, Japan

Wakayama Medical University

Wakayama, Japan

Outcomes

Primary Outcomes

Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Time frame: Up to 30 weeks.

Secondary Outcomes

The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Time frame: Up to 24 weeks.

The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Time frame: Up to 30 weeks.

The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Time frame: Up to 2 years.