FOLFOXIRI As Primary Treatment For Locally Advanced Pancreatic Cancer

Study Overview

FOLFOXIRI as Primary Treatment for 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.

N/A

Pancreatic Carcinoma Stage III

DRUG: FOLFOXIRI

FLAP study

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-01-27
First Submitted that Met QC Criteria 2015-01-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-01-30
First Posted (ESTIMATED) 2015-01-30	Results First Posted N/A	Last Verified 2015-01

Study Plan

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

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFOXIRI

DRUG: FOLFOXIRI

Primary Outcome Measures	Measure Description	Time Frame
Radical resection rate		6 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival		Within 24 months

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Evidence of distant metastases
Cardiovascular diseases
Contraindications to studied drugs

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record