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Trial record 12 of 267 for:    Pancreatic Cancer AND Resectable

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

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ClinicalTrials.gov Identifier: NCT02717091
Recruitment Status : Enrolling by invitation
First Posted : March 23, 2016
Last Update Posted : March 30, 2018
Sponsor:
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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: FOLFIRINOX
4 course of FILFIRINOX before surgery
Drug: FOLFIRINOX
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.



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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
Criteria

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
ClinicalTrials.gov Identifier: NCT02717091     History of Changes
Other Study ID Numbers: NUDC1508
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
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
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs