<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04480268</url>
  </required_header>
  <id_info>
    <org_study_id>PACT31</org_study_id>
    <nct_id>NCT04480268</nct_id>
  </id_info>
  <brief_title>PAXG Out in the Country</brief_title>
  <acronym>OINC</acronym>
  <official_title>PAXG Out in the Country</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the reproducibility of PAXG regimen as&#xD;
      first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal&#xD;
      Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a&#xD;
      large volume center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic Ductal Adenocarcinoma (PDAC) is one of the most lethal malignancies, with a 5-year&#xD;
      overall survival (OS) rate for all stages combined lower than 10%, decreasing to 3% in&#xD;
      advanced disease. Additionally, PDAC is expected to become the 2nd leading cause for&#xD;
      cancer-related death by 2030. Chemotherapy still represents the only therapeutic option in&#xD;
      most cases, since 70% of PDAC patients exhibit metastatic or locally advanced disease at&#xD;
      diagnosis. Concerning metastatic PDAC patients, combination chemotherapy has resulted in&#xD;
      improved survival compared with single-agent treatment. Based on promising phase I/II&#xD;
      studies, the PAXG regimen (cisplatin, nab-paclitaxel, capecitabine and gemcitabine) has been&#xD;
      recommended for first-line treatment of metastatic PDAC patients in the 2019 edition of&#xD;
      Associazione Italiana Oncologia Medica (AIOM) guidelines. Also, this regimen was approved by&#xD;
      the Agenzia Italiana del Farmaco (AIFA) as first therapy of borderline-resectable, locally&#xD;
      advanced and metastatic PDAC patients with good performance status (ECOG 0-1) and age 18-75&#xD;
      years.&#xD;
&#xD;
      Description of the intervention (schedule of visits):&#xD;
&#xD;
      All PDAC patients who are treated with PAXG regimen as first-line/primary chemotherapy at the&#xD;
      participating institutions from January 1st 2020 to December 31st 2020 according to inclusion&#xD;
      and exclusion criteria will be included in the present study.&#xD;
&#xD;
      Power size calculation:&#xD;
&#xD;
      The sample size will be as large as possible with a competitive enrollment. All patients&#xD;
      treated by the PAXG regimen during 2020 in the participating institutions will be included&#xD;
      into the trial. The investigators hypothesize that at least 175 patients (60% metastatic and&#xD;
      40% non-metastatic) from about 30 Italian centers will be enrolled by the end of the year.&#xD;
      Such a sample size, or a larger one, will allow to compute in both groups a 95% confident&#xD;
      interval of the 1-year OS with at least 10% margin of error, assuming to observe a (target)&#xD;
      1-year OS of 60% for metastatic patients and of 80% for non-metastatic. The trial will be&#xD;
      considered successful if the target 1-year OS will fall into the corresponding computed 95%&#xD;
      CI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival at 1 year (PFS-1yr)</measure>
    <time_frame>12 months after the diagnosis</time_frame>
    <description>Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical Response</measure>
    <time_frame>12 months after the diagnosis</time_frame>
    <description>To evaluate the CA19-9 response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological Response</measure>
    <time_frame>12 months after the diagnosis</time_frame>
    <description>To evaluate the RECIST radiological response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity profile</measure>
    <time_frame>12 months after the diagnosis</time_frame>
    <description>To evaluate drugs toxicity and safety according to according to the &quot;Common Toxicity Criteria&quot; defined by NCI (US) and integrated by NCIC (Canada) version 5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>5 year after the diagnosis</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>5 year after the diagnosis</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">175</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy</intervention_name>
    <description>The PAXG regimen includes:&#xD;
nab-paclitaxel 150 mg/m2 on day 1 and 15 of each cycle;&#xD;
cisplatin 30 mg/m2 on day 1 and 15 of each cycle;&#xD;
capecitabine 1250 mg/m2 on 1 day to 28 of each cycle;&#xD;
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.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cyto/histological diagnosis of pancreatic adenocarcinoma;&#xD;
&#xD;
          -  locally advanced and metastatic disease corresponding to clinical stage III-IV&#xD;
             according to TNM 8th Ed. 2017 and borderline resectable disease as anatomically&#xD;
             defined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma and&#xD;
             biologically defined according to the International consensus on definition and&#xD;
             criteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 &gt; 500&#xD;
             IU/ml);&#xD;
&#xD;
          -  ECOG Performance Status ≤1;&#xD;
&#xD;
          -  adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥&#xD;
             100000/mm3, Hb ≥10 g/dl), kidney function (serum creatinine &lt; 1.5 mg/dL) and liver&#xD;
             function (ALT and AST &lt; 3 ULN and Serum total bilirubin ≤ 1.5 ULN);&#xD;
&#xD;
          -  Patient of child-bearing potential must agree to use two medically acceptable methods&#xD;
             of contraception (one for the patient and one for the partner) during the study and&#xD;
             for 4 months after the last study treatment intake for women and 6 months for men;&#xD;
&#xD;
          -  patients must have received at least 1 cycle (28 days) of the PAXG treatment for the&#xD;
             disease within the timeframe starting from January 1 2020 to December 31st 2020 ;&#xD;
&#xD;
          -  patient information and signed written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous chemotherapy treatment for recurrent disease;&#xD;
&#xD;
          -  concurrent treatment with experimental drugs;&#xD;
&#xD;
          -  presence of symptomatic brain metastases;&#xD;
&#xD;
          -  heart failure, arrhythmia and/or acute myocardial infarction within 6 months prior to&#xD;
             the beginning of PAXG treatment;&#xD;
&#xD;
          -  women on pregnancy or lactation;&#xD;
&#xD;
          -  history of interstitial lung disease;&#xD;
&#xD;
          -  history of connective tissue diseases (systemic lupus erythematosus, systemic&#xD;
             sclerosis, etc. ).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Reni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Ospedale San Raffaele</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giulia Orsi, MD</last_name>
    <phone>+390226436620</phone>
    <email>orsi.giulia@hsr.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Maddalena Valente, PhD</last_name>
    <phone>+390226437623</phone>
    <email>valente.mariamaddalena@hsr.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IRCCS Centro di Riferimento Oncologico (CRO)</name>
      <address>
        <city>Aviano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Angela Buonadonna, MD</last_name>
      <email>abuonadonna@cro.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto dei tumori Giovanni Paolo II</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicola Silvestris, MD</last_name>
      <email>silvestrisnicola@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AULSS 1 di Belluno</name>
      <address>
        <city>Belluno</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fable Zustovich, MD</last_name>
      <email>fable.zustovich@aulss1.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ASST Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Barbara Merelli, MD</last_name>
      <email>bmerelli@asst-pg23.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maria Cristina Di Marco, MD, PhD</last_name>
      <email>mariacristina.dimarco@unibo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera AOU di Cagliari</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mario Scartozzi, MD</last_name>
      <email>marioscartozzi@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale di Carpi</name>
      <address>
        <city>Carpi</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ilaria Bernardini, MD</last_name>
      <email>i.bernardini@ausl.mo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>USL Toscana Nord Ovest</name>
      <address>
        <city>Carrara</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andrea Mambrini, MD</last_name>
      <email>andrea.mambrini@uslnordovest.toscana.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione Istituto Giglio</name>
      <address>
        <city>Cefalù</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Massimiliano Spada, MD</last_name>
      <email>maxspa75@yahoo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedaliera Sant' Anna di Como Asst Lariana</name>
      <address>
        <city>Como</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Monica Giordano, MD</last_name>
      <email>monica.giordano@asst-lariana.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia</name>
      <address>
        <city>Foggia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Matteo Landriscina, MD, PhD</last_name>
      <email>matteo.landriscina@unifg.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ASST Rhodense</name>
      <address>
        <city>Garbagnate</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Silvia Della Torre, MD</last_name>
      <email>sdellatorre@asst-rhodense.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Moriggia Pelascini</name>
      <address>
        <city>Gravedona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Giuseppe Valmadre, MD</last_name>
      <email>gvalmadre@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Generale Provinciale di Macerata</name>
      <address>
        <city>Macerata</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luca Faloppi, MD, PhD</last_name>
      <email>luca.faloppi@sanita.marche.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Irccs Irst</name>
      <address>
        <city>Meldola</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Giovanni Luca Frassineti, MD</last_name>
      <email>luca.frassineti@irst.emr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ASST Melegnano e Della Martesana</name>
      <address>
        <city>Melegnano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andrea De Monte, MD</last_name>
      <email>andrea.demonte@asst-melegnano-martesana.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS San Raffaele Medical Oncology Unit</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giulia Orsi, MD</last_name>
      <phone>+39 02 26437602</phone>
      <email>orsi.giulia@hsr.it</email>
    </contact>
    <contact_backup>
      <last_name>Maria Maddalena Valente, PhD</last_name>
      <phone>+39 02 26437623</phone>
      <email>valente.mariamaddalena@hsr.it</email>
    </contact_backup>
    <investigator>
      <last_name>Michele Reni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto IRCCS</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sara Lonardi, MD</last_name>
      <email>sara.lonardi@iov.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Civico di Palermo</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Livio Blasi, MD</last_name>
      <email>livio.blasi61@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Parma</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ingrid Garajova, MD, PhD</last_name>
      <email>igarajova@ao.pr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Piacenza</name>
      <address>
        <city>Piacenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luigi Cavanna, MD</last_name>
      <email>l.cavanna@ausl.pc.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Giovanni Paolo II-Maria Paternò</name>
      <address>
        <city>Ragusa</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stefano Cordio, MD</last_name>
      <email>stefano.cordio@asp.rg.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona</name>
      <address>
        <city>Salerno</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Clementina Savastano, MD</last_name>
      <email>savastano.clementina@tiscali.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AULSS 4 Veneto Orientale</name>
      <address>
        <city>San Donà Di Piave</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Silvia Zanon, MD</last_name>
      <email>silvia.zanon@aulss4.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Evaristo Maiello, MD</last_name>
      <email>e.maiello@operapadrepio.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ordine Mauriziano</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Massimo Di Maio, MD</last_name>
      <email>massimo.dimaio@unito.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Molinette</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maria Antonietta Satolli, MD, PhD</last_name>
      <email>mariaantonietta.satolli@unito.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Universitaria Integrata</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Giovanni Gerardo Cardellino, MD</last_name>
      <email>giovanni.cardellino@asufc.sanita.fvg.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ASST Sette Laghi</name>
      <address>
        <city>Varese</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stefania Gobba, MD</last_name>
      <email>stefaniamaria.gobba@asst-settelaghi.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est</name>
      <address>
        <city>Vicenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Giuseppe Aprile, MD</last_name>
      <email>giuseppe.aprile@ulss8.veneto.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21626049</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27404453</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30220407</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30149366</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
    <investigator_full_name>Michele Reni</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Combination chemotherapy</keyword>
  <keyword>PAXG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04480268
org study id: PACT31
nct id: NCT04480268
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival at 1 year (PFS-1yr)
time frame: 12 months after the diagnosis
description: Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
measure: Biochemical Response
time frame: 12 months after the diagnosis
description: To evaluate the CA19-9 response rate
measure: Radiological Response
time frame: 12 months after the diagnosis
description: To evaluate the RECIST radiological response
measure: Toxicity profile
time frame: 12 months after the diagnosis
description: 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
measure: Progression-free survival (PFS)
time frame: 5 year after the diagnosis
description: 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.
measure: Overall Survival (OS)
time frame: 5 year after the diagnosis
description: 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.
intervention type: Drug
intervention name: PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
description: 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.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michele Reni, MD
role: Principal Investigator
affiliation: IRCCS Ospedale San Raffaele
last name: Giulia Orsi, MD
phone: +390226436620
email: orsi.giulia@hsr.it
last name: Maria Maddalena Valente, PhD
phone: +390226437623
email: valente.mariamaddalena@hsr.it
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country: Italy
citation: 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.
PMID: 21626049
citation: 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.
PMID: 27404453
citation: 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.
PMID: 30220407
citation: 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.
PMID: 30149366
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele
investigator full name: Michele Reni
investigator title: MD
mesh term: Adenocarcinoma
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Capecitabine
sharing ipd: No