Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX

NCT ID: NCT03590275

Last Updated: 2018-07-18

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

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-02

Study Completion Date

2018-06-30

Brief Summary

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The aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with FOLFIRINOX regimen. Primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients.

Detailed Description

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Conditions

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Pancreatic Cancer Non-resectable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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FOLFIRINOX

Patients treated with first-line FOLFIRINOX (oxaliplatin + irinotecan + lederfolin + 5-fluorouracil) as per clinical practice were included in the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \>18 years
* citologically or histologically confirmed pancreatic carcinoma
* disease stage III or IV according to the American Joint Committee on Cancer (AJCC) staging system
* access to clinical informations collected before first-line starting
* availability of objective response evaluation and survival data
* written informed consent

Exclusion Criteria

* diagnosis of other neoplasia than pancreatic carcinoma
* treatment with drugs other than FOLFIRINOX
* treatment with experimental drugs in combination with FOLFIRINOX
* unavailability of clinical and pathological data
Minimum Eligible Age

18 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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Alfredo Falcone

Prof. Alfredo Falcone

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorenzo Fornaro, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero, Universitaria Pisana

Locations

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Oncologia ASL BI

Ponderano, Biella, Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Forlì Cesena, Italy

Site Status

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS

Candiolo, Torino, Italy

Site Status

ASL VCO, Ospedale Castelli Verbania

Verbania, Torino, Italy

Site Status

A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica

Pisa, , Italy

Site Status

P.O. Molinette Oncologia 1

Torino, , Italy

Site Status

A.O. Ordine Mauriziano

Torino, , Italy

Site Status

Countries

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Italy

References

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Fornaro L, Leone F, Vienot A, Casadei-Gardini A, Vivaldi C, Lievre A, Lombardi P, De Luca E, Vernerey D, Sperti E, Musettini G, Satolli MA, Edeline J, Spadi R, Neuzillet C, Falcone A, Pasquini G, Clerico M, Passardi A, Buscaglia P, Meurisse A, Aglietta M, Brac C, Vasile E, Montagnani F. Validated Nomogram Predicting 6-Month Survival in Pancreatic Cancer Patients Receiving First-Line 5-Fluorouracil, Oxaliplatin, and Irinotecan. Clin Colorectal Cancer. 2019 Dec;18(4):e394-e401. doi: 10.1016/j.clcc.2019.08.004. Epub 2019 Sep 4.

Reference Type DERIVED
PMID: 31564556 (View on PubMed)

Other Identifiers

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HOPE

Identifier Type: -

Identifier Source: org_study_id

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