Overview

This trial is active, not recruiting.

Condition pancreatic cancer.
Treatment firinox
Phase phase 1
Sponsor Wakayama Medical University
Start date April 2014
End date February 2017
Trial size 10 participants
Trial identifier NCT02148549, FIRINOX, UMIN000013809

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients
firinox Oxaliplatin, Irinotecan, 5-FU.
FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Primary Outcomes

Measure
Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
time frame: Up to 30 weeks.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 20 years up to 74 years old.

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

Additional Information

Official title The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
Principal investigator Hiroki Yamaue, M.D., PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Wakayama Medical University.