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

Phase 2

• Conditions: Borderline Resectable Pancreatic Cancer
• Interventions: Drug: FOLFIRINOX; Drug: gemcitabine + nab-paclitaxel

• Registration Number: NCT02717091
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-23
• Primary Completion: 2020-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFIRINOX	FOLFIRINOX	4 course of FILFIRINOX before surgery
GEM + nab-PTX	gemcitabine + nab-paclitaxel	2 course of GEM + nab-PTX before surgery

Primary Outcome Measures

Name	Time	Method
R0 resection rate	3 months	surgery is supposed to be performed 3 months after the initiation of chemotherapy

Secondary Outcome Measures

Name	Time	Method
relative dose intensity	3 months	chemotherapy is supposed to take 3 months
surgical complication	1 month after the surgery
tumor response	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
overall survival	3 years after the surgery
adverse event	3 months	chemotherapy is supposed to take 3 months
disease free survival	3 years after the surgery
completion rate of chemotherapy	3 months	chemotherapy is supposed to take 3 months
quality of the tumor	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.