FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer (FLAP)

January 27, 2015 updated by: Enrico Vasile, Azienda Ospedaliero, Universitaria Pisana

Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer

The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible.

After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.

In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy.

Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy.

Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage III unresectable pancreatic cancer defined for:

    • extended encasement of superior mesenteric artery or celiac axis/hepatic artery
    • both arterial and venous (portal vein/superior mesenteric vein) encasement
    • unreconstructible vessel encasement
  • ECOG Performance Status 0-1
  • Age 18-75
  • Adequate liver, renal and bone marrow function

Exclusion Criteria:

  • Evidence of distant metastases
  • Cardiovascular diseases
  • Contraindications to studied drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FOLFOXIRI
Drug: FOLFOXIRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radical resection rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Within 24 months
Within 24 months

Other Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Within 36 months
Within 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: within all the treatment period
within all the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (ESTIMATE)

January 30, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLAP study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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