Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study (FIRINOX)

The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer

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 Overview

• Status: Completed
• Conditions: Patients With Borderline Resectable Pancreatic Cancer
• Intervention / Treatment: Drug: FIRINOX

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan
    • Hiroshima University
  • Osaka, Japan
    • Osaka City University
  • Osaka, Japan
    • Osaka Medical Center for Cancer and CVD
  • Wakayama, Japan, 641-8510
    • Wakayama Medical University
  • Aichi
    • Nagoya, Aichi, Japan
      • Nagoya University
  • Hyogo
    • Kobe, Hyogo, Japan
      • Kobe University
  • Nara
    • Kashihara, Nara, Japan
      • Nara Prefectual Medical University
  • Osaka
    • Hirakata, Osaka, Japan
      • Kansai Medical University
    • Suita, Osaka, Japan
      • Osaka University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.; Other Names: Oxaliplatin, Irinotecan, 5-FU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Wakayama Medical University
• Investigators: Principal Investigator: Hiroki Yamaue, M.D., PhD, Wakayama Medical University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: R0 resection; Borderline resectable pancreatic cancer; Resection rate; Optimal schedule
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Oxaliplatin; Irinotecan
• Other Study ID Numbers: FIRINOX; UMIN000013809 (Other Identifier: UMIN)