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

Primary Purpose

Patients With Borderline Resectable Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
FIRINOX
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Borderline Resectable Pancreatic Cancer focused on measuring Borderline resectable pancreatic cancer, R0 resection, Resection rate, Optimal schedule

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya University
  • Kobe University
  • Nara Prefectual Medical University
  • Kansai Medical University
  • Osaka University
  • Hiroshima University
  • Osaka City University
  • Osaka Medical Center for Cancer and CVD
  • Wakayama Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optimal chemotherapy courses

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2014
Last Updated
October 2, 2019
Sponsor
Wakayama Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02148549
Brief Title
Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study
Acronym
FIRINOX
Official Title
The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wakayama Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Borderline Resectable Pancreatic Cancer
Keywords
Borderline resectable pancreatic cancer, R0 resection, Resection rate, Optimal schedule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal chemotherapy courses
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients
Intervention Type
Drug
Intervention Name(s)
FIRINOX
Other Intervention Name(s)
Oxaliplatin, Irinotecan, 5-FU.
Intervention Description
FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.
Primary Outcome Measure Information:
Title
Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Description
Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Time Frame
Up to 30 weeks.
Secondary Outcome Measure Information:
Title
The resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Time Frame
Up to 24 weeks.
Title
The R0 resection rate of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Time Frame
Up to 30 weeks.
Title
The optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Time Frame
Up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically proven invasive pancreatic ductal carcinoma Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2) Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroki Yamaue, M.D., PhD
Organizational Affiliation
Wakayama Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya University
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Kobe University
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Nara Prefectual Medical University
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Kansai Medical University
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Osaka University
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Hiroshima University
City
Hiroshima
Country
Japan
Facility Name
Osaka City University
City
Osaka
Country
Japan
Facility Name
Osaka Medical Center for Cancer and CVD
City
Osaka
Country
Japan
Facility Name
Wakayama Medical University
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

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Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

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