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

Azienda Ospedaliero, Universitaria Pisana343 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

343

Conditions

Pancreatic Cancer Non-resectable

Interventions

FOLFIRINOXDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Oncologia ASL BI

Ponderano, Biella, Italy

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

ASL VCO, Ospedale Castelli Verbania

Verbania, Torino, Italy

Outcomes

Primary Outcomes

Overall survival

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.

Time frame: up to 2 years

Secondary Outcomes

Progression-free survival

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.

Time frame: up to 2 years

Response rate

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.

Time frame: up to 2 years

Toxicity rate

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.

Time frame: up to 2 years

Data from ClinicalTrials.gov

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