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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRINOX | Drug | Patients treated with first-line FOLFIRINOX (oxaliplatin + irinotecan + lederfolin + 5-fluorouracil) as per clinical practice were included in the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable advanced pancreatic carcinoma treated with FOLFIRINOX at the involved institutions between 2010 and 2017 will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Fornaro, MD | Azienda Ospedaliero, Universitaria Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncologia ASL BI | Ponderano | Biella | 13875 | Italy | ||
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31564556 | Derived | 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. |
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| 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. |
| 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. | up to 2 years |
| Meldola |
| Forlì Cesena |
| 47014 |
| Italy |
| Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS | Candiolo | Torino | 10060 | Italy |
| ASL VCO, Ospedale Castelli Verbania | Verbania | Torino | 28922 | Italy |
| A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica | Pisa | 56012 | Italy |
| P.O. Molinette Oncologia 1 | Torino | 10126 | Italy |
| A.O. Ordine Mauriziano | Torino | 10128 | Italy |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000627770 | folfirinox |
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