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Trial record 53 of 2838 for:    Pancreatic Cancer

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

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ClinicalTrials.gov Identifier: NCT02148549
Recruitment Status : Unknown
Verified July 2015 by Hiroki Yamaue, Wakayama Medical University.
Recruitment status was:  Active, not recruiting
First Posted : May 28, 2014
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer. Drug: FIRINOX Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer
Study Start Date : April 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Irinotecan

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 Name: Oxaliplatin, Irinotecan, 5-FU.




Primary Outcome Measures :
  1. Number of participants with toxicity of FIRINOX therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks. ]
    Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.


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


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148549


Locations
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Japan
Nagoya University
Nagoya, Aichi, Japan
Kobe University
Kobe, Hyogo, 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, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
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Principal Investigator: Hiroki Yamaue, M.D., PhD Wakayama Medical University

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Responsible Party: Hiroki Yamaue, Dean & Professor, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT02148549     History of Changes
Other Study ID Numbers: FIRINOX
UMIN000013809 ( Other Identifier: UMIN )
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Hiroki Yamaue, Wakayama Medical University:
Borderline resectable pancreatic cancer
R0 resection
Resection rate
Optimal schedule

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action