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

Completed

• Conditions: Pancreatic Cancer Non-resectable

• Registration Number: NCT03590275
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2018-01-18
• Study Completion: 2018-06-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-06
• Last Update Submitted: 2018-07-06
• Study First Posted: 2018-07-18
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	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.
Response rate	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.
Toxicity rate	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.

Trial Locations

Locations (7)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS; 🇮🇹 Meldola, Forlì Cesena, Italy

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS; 🇮🇹 Candiolo, Torino, Italy

A.O. Ordine Mauriziano; 🇮🇹 Torino, Italy

ASL VCO, Ospedale Castelli Verbania; 🇮🇹 Verbania, Torino, Italy

A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica; 🇮🇹 Pisa, Italy

Oncologia ASL BI; 🇮🇹 Ponderano, Biella, Italy

P.O. Molinette Oncologia 1; 🇮🇹 Torino, Italy