NCT02717091

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

4.9 years

First QC Date

February 11, 2016

Last Update Submit

September 8, 2020

Conditions

Borderline Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    surgery is supposed to be performed 3 months after the initiation of chemotherapy

    3 months

Secondary Outcomes (8)

  • completion rate of chemotherapy

    3 months

  • relative dose intensity

    3 months

  • adverse event

    3 months

  • tumor response

    3 months

  • disease free survival

    3 years after the surgery

  • +3 more secondary outcomes

Study Arms (2)

FOLFIRINOX

EXPERIMENTAL

4 course of FILFIRINOX before surgery

Drug: FOLFIRINOX

GEM + nab-PTX

EXPERIMENTAL

2 course of GEM + nab-PTX before surgery

Drug: gemcitabine + nab-paclitaxel

Interventions

FOLFIRINOXDRUG
FOLFIRINOX
gemcitabine + nab-paclitaxelDRUG
GEM + nab-PTX

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
  • first treatment for pancreatic cancer
  • performance status 0 or 1
  • adequate one marrow function
  • adequate renal function
  • obtained informed consent

You may not qualify if:

  • other active concomitant malignancies
  • other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
  • pregnant women
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

folfirinoxGemcitabine130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncology

Study Record Dates

First Submitted

February 11, 2016

First Posted

March 23, 2016

Study Start

July 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2023

Last Updated

September 10, 2020

Record last verified: 2020-09