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

September 8, 2020 updated by: Junpei Yamaguchi, Nagoya University

Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 3 months
surgery is supposed to be performed 3 months after the initiation of chemotherapy
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
completion rate of chemotherapy
Time Frame: 3 months
chemotherapy is supposed to take 3 months
3 months
relative dose intensity
Time Frame: 3 months
chemotherapy is supposed to take 3 months
3 months
adverse event
Time Frame: 3 months
chemotherapy is supposed to take 3 months
3 months
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
3 months
disease free survival
Time Frame: 3 years after the surgery
3 years after the surgery
overall survival
Time Frame: 3 years after the surgery
3 years after the surgery
surgical complication
Time Frame: 1 month after the surgery
1 month after the surgery
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUDC1508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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