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FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

NCT ID: NCT02351219

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Carcinoma Stage III

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOXIRI

Group Type EXPERIMENTAL

FOLFOXIRI

Intervention Type DRUG

Interventions

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FOLFOXIRI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Enrico Vasile

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Site Status

Countries

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Italy

Other Identifiers

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FLAP study

Identifier Type: -

Identifier Source: org_study_id