Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
175 participants
INTERVENTIONAL
2020-07-08
2026-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
The PAXG regimen includes:
* nab-paclitaxel 150 mg/m2 on day 1 and 15 of each cycle;
* cisplatin 30 mg/m2 on day 1 and 15 of each cycle;
* capecitabine 1250 mg/m2 on 1 day to 28 of each cycle;
* gemcitabine 800 mg/m2 on day 1 and 15 of each cycle. Each cycle lasts 28 days. Patients are treated until maximal response, disease progression or unacceptable toxicity.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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. ).
18 Years
75 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Michele Reni
MD
Principal Investigators
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Michele Reni, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Locations
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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
Padua, , 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
Countries
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Central Contacts
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Facility Contacts
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References
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Reni M, Cereda S, Rognone A, Belli C, Ghidini M, Longoni S, Fugazza C, Rezzonico S, Passoni P, Slim N, Balzano G, Nicoletti R, Cappio S, Doglioni C, Villa E. A randomized phase II trial of two different 4-drug combinations in advanced pancreatic adenocarcinoma: cisplatin, capecitabine, gemcitabine plus either epirubicin or docetaxel (PEXG or PDXG regimen). Cancer Chemother Pharmacol. 2012 Jan;69(1):115-23. doi: 10.1007/s00280-011-1680-2. Epub 2011 May 28.
Reni M, Balzano G, Zanon S, Passoni P, Nicoletti R, Arcidiacono PG, Pepe G, Doglioni C, Fugazza C, Ceraulo D, Falconi M, Gianni L. Phase 1B trial of Nab-paclitaxel plus gemcitabine, capecitabine, and cisplatin (PAXG regimen) in patients with unresectable or borderline resectable pancreatic adenocarcinoma. Br J Cancer. 2016 Jul 26;115(3):290-6. doi: 10.1038/bjc.2016.209. Epub 2016 Jul 12.
Reni M, Zanon S, Peretti U, Chiaravalli M, Barone D, Pircher C, Balzano G, Macchini M, Romi S, Gritti E, Mazza E, Nicoletti R, Doglioni C, Falconi M, Gianni L. Nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in metastatic pancreatic adenocarcinoma (PACT-19): a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):691-697. doi: 10.1016/S2468-1253(18)30196-1. Epub 2018 Jul 7.
Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.
Other Identifiers
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PACT31
Identifier Type: -
Identifier Source: org_study_id
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