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

NCT ID: NCT02717091

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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Conditions

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Borderline Resectable Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFIRINOX

4 course of FILFIRINOX before surgery

Group Type EXPERIMENTAL

FOLFIRINOX

Intervention Type DRUG

GEM + nab-PTX

2 course of GEM + nab-PTX before surgery

Group Type EXPERIMENTAL

gemcitabine + nab-paclitaxel

Intervention Type DRUG

Interventions

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FOLFIRINOX

Intervention Type DRUG

gemcitabine + nab-paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagoya University

OTHER

Sponsor Role lead

Responsible Party

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Junpei Yamaguchi

Surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NUDC1508

Identifier Type: -

Identifier Source: org_study_id

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