NCT01397019

Brief Summary

Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan \& 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_2 pancreatic-cancer

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

3 active sites

Status
completed

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

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

4.8 years

First QC Date

July 18, 2011

Last Update Submit

October 29, 2020

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerChemotherapyChemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • 2 year survival rate

    2 years

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL
Drug: Oxaliplatin, irinotecan, 5-FU & leucovorin

Interventions

Oxaliplatin, irinotecan, 5-FU & leucovorinDRUG

FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors

FOLFIRINOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-metastatic pancreatic cancer
  • Performance status 0-1
  • Bilirubin \< 1.5 UNL
  • Written informed consent

You may not qualify if:

  • no prior abdominal radiotherapy
  • no prior chemotherapy for pancratic cancer
  • no severe comorbidity
  • patients must be able to undergo potential abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

OxaliplatinIrinotecanFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Per Pfeiffer, Professor

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2016

Study Completion

February 1, 2018

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

DK(3)