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Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02717091
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : September 10, 2020
Information provided by (Responsible Party):
Junpei Yamaguchi, Nagoya University

Brief Summary:
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.

Condition or disease Intervention/treatment Phase
Borderline Resectable Pancreatic Cancer Drug: FOLFIRINOX Drug: gemcitabine + nab-paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
Study Start Date : July 2015
Actual Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: FOLFIRINOX
4 course of FILFIRINOX before surgery
Experimental: GEM + nab-PTX
2 course of GEM + nab-PTX before surgery
Drug: gemcitabine + nab-paclitaxel

Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 3 months ]
    surgery is supposed to be performed 3 months after the initiation of chemotherapy

Secondary Outcome Measures :
  1. completion rate of chemotherapy [ Time Frame: 3 months ]
    chemotherapy is supposed to take 3 months

  2. relative dose intensity [ Time Frame: 3 months ]
    chemotherapy is supposed to take 3 months

  3. adverse event [ Time Frame: 3 months ]
    chemotherapy is supposed to take 3 months

  4. tumor response [ Time Frame: 3 months ]
    tumor response to chemotherapy will be assessed based on Response Evaluation Criteria In Solid Tumor (RECIST). CR: Complete Response, PR: Partial Response, PD: Progression, SD: Stable Disease, NE: Not Evaluable

  5. disease free survival [ Time Frame: 3 years after the surgery ]
  6. overall survival [ Time Frame: 3 years after the surgery ]
  7. surgical complication [ Time Frame: 1 month after the surgery ]
  8. quality of the tumor [ Time Frame: 3 months ]
    Chemotherapy is supposed to take 3 months. After the completion of chemotherapy, the quality of the tumor will be assessed by imaging findings, such as CT number and Standardized uptake value.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
  2. first treatment for pancreatic cancer
  3. performance status 0 or 1
  4. adequate one marrow function
  5. adequate renal function
  6. obtained informed consent

Exclusion Criteria:

  1. other active concomitant malignancies
  2. other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
  3. pregnant women
  4. no informed consent
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Responsible Party: Junpei Yamaguchi, Surgical Oncology, Nagoya University Identifier: NCT02717091    
Other Study ID Numbers: NUDC1508
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs