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Brief Title: PAXG Out in the Country
Official Title: PAXG Out in the Country
Study ID: NCT04480268
Brief Summary: The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center.
Detailed Description: Pancreatic Ductal Adenocarcinoma (PDAC) is one of the most lethal malignancies, with a 5-year overall survival (OS) rate for all stages combined lower than 10%, decreasing to 3% in advanced disease. Additionally, PDAC is expected to become the 2nd leading cause for cancer-related death by 2030. Chemotherapy still represents the only therapeutic option in most cases, since 70% of PDAC patients exhibit metastatic or locally advanced disease at diagnosis. Concerning metastatic PDAC patients, combination chemotherapy has resulted in improved survival compared with single-agent treatment. Based on promising phase I/II studies, the PAXG regimen (cisplatin, nab-paclitaxel, capecitabine and gemcitabine) has been recommended for first-line treatment of metastatic PDAC patients in the 2019 edition of Associazione Italiana Oncologia Medica (AIOM) guidelines. Also, this regimen was approved by the Agenzia Italiana del Farmaco (AIFA) as first therapy of borderline-resectable, locally advanced and metastatic PDAC patients with good performance status (ECOG 0-1) and age 18-75 years. Description of the intervention (schedule of visits): All PDAC patients who are treated with PAXG regimen as first-line/primary chemotherapy at the participating institutions from January 1st 2020 to December 31st 2020 according to inclusion and exclusion criteria will be included in the present study. Power size calculation: The sample size will be as large as possible with a competitive enrollment. All patients treated by the PAXG regimen during 2020 in the participating institutions will be included into the trial. The investigators hypothesize that at least 175 patients (60% metastatic and 40% non-metastatic) from about 30 Italian centers will be enrolled by the end of the year. Such a sample size, or a larger one, will allow to compute in both groups a 95% confident interval of the 1-year OS with at least 10% margin of error, assuming to observe a (target) 1-year OS of 60% for metastatic patients and of 80% for non-metastatic. The trial will be considered successful if the target 1-year OS will fall into the corresponding computed 95% CI.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS Centro di Riferimento Oncologico (CRO), Aviano, , Italy
Istituto dei tumori Giovanni Paolo II, Bari, , Italy
AULSS 1 di Belluno, Belluno, , Italy
ASST Papa Giovanni XXIII, Bergamo, , Italy
Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera AOU di Cagliari, Cagliari, , Italy
Ospedale di Carpi, Carpi, , Italy
USL Toscana Nord Ovest, Carrara, , Italy
Fondazione Istituto Giglio, Cefalù, , Italy
Ospedaliera Sant' Anna di Como Asst Lariana, Como, , Italy
Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia, Foggia, , Italy
ASST Rhodense, Garbagnate, , Italy
Ospedale Moriggia Pelascini, Gravedona, , Italy
Ospedale Generale Provinciale di Macerata, Macerata, , Italy
Irccs Irst, Meldola, , Italy
ASST Melegnano e Della Martesana, Melegnano, , Italy
IRCCS San Raffaele Medical Oncology Unit, Milan, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Ospedale Civico di Palermo, Palermo, , Italy
Azienda Ospedaliera di Parma, Parma, , Italy
Azienda Ospedaliera di Piacenza, Piacenza, , Italy
Giovanni Paolo II-Maria Paternò, Ragusa, , Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona, Salerno, , Italy
AULSS 4 Veneto Orientale, San Donà Di Piave, , Italy
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
Azienda Ospedaliera Ordine Mauriziano, Torino, , Italy
Presidio Ospedaliero Molinette, Torino, , Italy
Azienda Sanitaria Universitaria Integrata, Udine, , Italy
ASST Sette Laghi, Varese, , Italy
Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est, Vicenza, , Italy
Name: Michele Reni, MD
Affiliation: IRCCS Ospedale San Raffaele
Role: PRINCIPAL_INVESTIGATOR