PAXG Out in the Country
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Registration Number
- NCT04480268
- Lead Sponsor
- IRCCS San Raffaele
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 175
- cyto/histological diagnosis of pancreatic adenocarcinoma;
- locally advanced and metastatic disease corresponding to clinical stage III-IV according to TNM 8th Ed. 2017 and borderline resectable disease as anatomically defined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma and biologically defined according to the International consensus on definition and criteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 > 500 IU/ml);
- ECOG Performance Status ≤1;
- adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl), kidney function (serum creatinine < 1.5 mg/dL) and liver function (ALT and AST < 3 ULN and Serum total bilirubin ≤ 1.5 ULN);
- Patient of child-bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men;
- patients must have received at least 1 cycle (28 days) of the PAXG treatment for the disease within the timeframe starting from January 1 2020 to December 31st 2020 ;
- patient information and signed written informed consent.
- previous chemotherapy treatment for recurrent disease;
- concurrent treatment with experimental drugs;
- presence of symptomatic brain metastases;
- heart failure, arrhythmia and/or acute myocardial infarction within 6 months prior to the beginning of PAXG treatment;
- women on pregnancy or lactation;
- history of interstitial lung disease;
- history of connective tissue diseases (systemic lupus erythematosus, systemic sclerosis, etc. ).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression-free survival at 1 year (PFS-1yr) 12 months after the diagnosis Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 5 year after the diagnosis To evaluate the progression-free survival (PFS), defined as the time between the date of registration and the date of documented radiological PD or death from any cause, whichever occurs first, or the date of last follow-up or last available tumour assessment if no further follow-up for disease progression is performed.
Overall Survival (OS) 5 year after the diagnosis To evaluate the overall survival (OS), defined as time between the date of registration and the date of death for any cause or the date they were last known to be alive.
Toxicity profile 12 months after the diagnosis To evaluate drugs toxicity and safety according to according to the "Common Toxicity Criteria" defined by NCI (US) and integrated by NCIC (Canada) version 5.0
Biochemical Response 12 months after the diagnosis To evaluate the CA19-9 response rate
Radiological Response 12 months after the diagnosis To evaluate the RECIST radiological response
Trial Locations
- Locations (30)
Azienda Sanitaria Universitaria Integrata
🇮🇹Udine, Italy
AULSS 4 Veneto Orientale
🇮🇹San Donà Di Piave, Italy
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
ASST Melegnano e Della Martesana
🇮🇹Melegnano, Italy
Irccs Irst
🇮🇹Meldola, Italy
IRCCS San Raffaele Medical Oncology Unit
🇮🇹Milan, Italy
Ospedale Civico di Palermo
🇮🇹Palermo, Italy
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Giovanni Paolo II-Maria Paternò
🇮🇹Ragusa, Italy
Azienda Ospedaliera di Piacenza
🇮🇹Piacenza, Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona
🇮🇹Salerno, Italy
IRCCS Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
Azienda Ospedaliera Ordine Mauriziano
🇮🇹Torino, Italy
ASST Sette Laghi
🇮🇹Varese, Italy
Presidio Ospedaliero Molinette
🇮🇹Torino, Italy
Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est
🇮🇹Vicenza, Italy