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

July 6, 2018 updated by: Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

343

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

      • Pisa, Italy, 56012
        • A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
      • Torino, Italy, 10126
        • P.O. Molinette Oncologia 1
      • Torino, Italy, 10128
        • A.O. Ordine Mauriziano
    • Biella
      • Ponderano, Biella, Italy, 13875
        • Oncologia ASL BI
    • Forlì Cesena
      • Meldola, Forlì Cesena, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS
      • Verbania, Torino, Italy, 28922
        • ASL VCO, Ospedale Castelli Verbania

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with unresectable advanced pancreatic carcinoma treated with FOLFIRINOX at the involved institutions between 2010 and 2017 will be included.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 2 years
Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: up to 2 years
Progression-free survival is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment.
up to 2 years
Response rate
Time Frame: up to 2 years
Response rate is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria vers. 1.1.
up to 2 years
Toxicity rate
Time Frame: up to 2 years
Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing treatment-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria (version 4.0), during chemotherapy.
up to 2 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lorenzo Fornaro, MD, Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

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

Study Start (ACTUAL)

October 2, 2017

Primary Completion (ACTUAL)

January 18, 2018

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (ACTUAL)

July 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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