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

Tokai National Higher Education and Research System

Status and phase: Unknown; Phase 2

Conditions: Borderline Resectable Pancreatic Cancer

Treatments: Drug: gemcitabine + nab-paclitaxel; Drug: FOLFIRINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT02717091

NUDC1508

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

FOLFIRINOX

Experimental group

Description:

4 course of FILFIRINOX before surgery

Treatment:

Drug: FOLFIRINOX

GEM + nab-PTX

Experimental group

Description:

2 course of GEM + nab-PTX before surgery

Treatment:

Drug: gemcitabine + nab-paclitaxel