- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590275
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
Conditions
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
-
-
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Pisa, Italy, 56012
- A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
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Torino, Italy, 10126
- P.O. Molinette Oncologia 1
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Torino, Italy, 10128
- A.O. Ordine Mauriziano
-
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Biella
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Ponderano, Biella, Italy, 13875
- Oncologia ASL BI
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Forlì Cesena
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Meldola, Forlì Cesena, Italy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
-
-
Torino
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Candiolo, Torino, Italy, 10060
- Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOPE
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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