Clinical trial NCT03590275: Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX
Official title: Observational Retrospective Study of Evaluation of Prognostic Factors in Advanced Pancreatic Cancer Patients Treated With FOLFIRINOX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer Non-resectable
Keywords: pancreatic cancer
chemotherapy
FOLFIRINOX
prognostic
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: up to 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to 2 years
measure: Response rate
timeFrame: up to 2 years
measure: Toxicity rate
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ponderano
country: Italy
facility: Oncologia ASL BI
state: Biella
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
state: Forlì Cesena
city: Candiolo
country: Italy
facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS
state: Torino
city: Verbania
country: Italy
facility: ASL VCO, Ospedale Castelli Verbania
state: Torino
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
city: Torino
country: Italy
facility: P.O. Molinette Oncologia 1
city: Torino
country: Italy
facility: A.O. Ordine Mauriziano
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Lorenzo Fornaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.