PAXG Out in the Country
OINC
1 other identifier
interventional
175
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2020
Longer than P75 for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2020
CompletedFirst Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedFebruary 10, 2021
February 1, 2021
1.5 years
July 14, 2020
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival at 1 year (PFS-1yr)
Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
12 months after the diagnosis
Secondary Outcomes (5)
Biochemical Response
12 months after the diagnosis
Radiological Response
12 months after the diagnosis
Toxicity profile
12 months after the diagnosis
Progression-free survival (PFS)
5 year after the diagnosis
Overall Survival (OS)
5 year after the diagnosis
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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. ).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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, 20132, 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
Related Publications (4)
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: 21626049BACKGROUNDReni 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: 27404453BACKGROUNDReni 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: 30220407BACKGROUNDReni 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: 30149366BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Reni, MD
IRCCS Ospedale San Raffaele
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 21, 2020
Study Start
July 8, 2020
Primary Completion
January 1, 2022
Study Completion
January 1, 2026
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share