Neoadjuvant FIRINOX For Borderline Resectable Pancreatic Cancer - A Pilot Study

Study Overview

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

Patients With Borderline Resectable Pancreatic Cancer

DRUG: FIRINOX

FIRINOX
UMIN000013809 (OTHER Identifier) (OTHER: UMIN)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-10-02
First Submitted that Met QC Criteria 2014-05-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-10-07
First Posted (ACTUAL) 2014-05-28	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Optimal chemotherapy courses Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients	DRUG: FIRINOX FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Optimal chemotherapy courses

Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients

DRUG: FIRINOX

FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Primary Outcome Measures	Measure Description	Time Frame
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.	Up to 30 weeks.

Secondary Outcome Measures	Measure Description	Time Frame
The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.		Up to 24 weeks.
The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.		Up to 30 weeks.
The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.		Up to 2 years.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Pathologically proven invasive pancreatic ductal carcinoma
Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Hiroki Yamaue, M.D., PhD, Wakayama Medical University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record