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PAXG Out in the Country (OINC)

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Combination chemotherapy, PAXG

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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. ).

Sites / Locations

  • IRCCS Centro di Riferimento Oncologico (CRO)
  • Istituto dei tumori Giovanni Paolo II
  • AULSS 1 di Belluno
  • ASST Papa Giovanni XXIII
  • Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi
  • Azienda Ospedaliera AOU di Cagliari
  • Ospedale di Carpi
  • USL Toscana Nord Ovest
  • Fondazione Istituto Giglio
  • Ospedaliera Sant' Anna di Como Asst Lariana
  • Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia
  • ASST Rhodense
  • Ospedale Moriggia Pelascini
  • Ospedale Generale Provinciale di Macerata
  • Irccs Irst
  • ASST Melegnano e Della Martesana
  • IRCCS San Raffaele Medical Oncology UnitRecruiting
  • Istituto Oncologico Veneto IRCCS
  • Ospedale Civico di Palermo
  • Azienda Ospedaliera di Parma
  • Azienda Ospedaliera di Piacenza
  • Giovanni Paolo II-Maria Paternò
  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona
  • AULSS 4 Veneto Orientale
  • IRCCS Casa Sollievo della Sofferenza
  • Azienda Ospedaliera Ordine Mauriziano
  • Presidio Ospedaliero Molinette
  • Azienda Sanitaria Universitaria Integrata
  • ASST Sette Laghi
  • Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biochemical Response
To evaluate the CA19-9 response rate
Radiological Response
To evaluate the RECIST radiological response
Toxicity profile
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
Progression-free survival (PFS)
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)
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.

Full Information

First Posted
July 14, 2020
Last Updated
February 8, 2021
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT04480268
Brief Title
PAXG Out in the Country
Acronym
OINC
Official Title
PAXG Out in the Country
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
Combination chemotherapy, PAXG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Progression-free survival at 1 year (PFS-1yr)
Description
Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
Time Frame
12 months after the diagnosis
Secondary Outcome Measure Information:
Title
Biochemical Response
Description
To evaluate the CA19-9 response rate
Time Frame
12 months after the diagnosis
Title
Radiological Response
Description
To evaluate the RECIST radiological response
Time Frame
12 months after the diagnosis
Title
Toxicity profile
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
Time Frame
12 months after the diagnosis
Title
Progression-free survival (PFS)
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.
Time Frame
5 year after the diagnosis
Title
Overall Survival (OS)
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.
Time Frame
5 year after the diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. ).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Orsi, MD
Phone
+390226436620
Email
orsi.giulia@hsr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Maddalena Valente, PhD
Phone
+390226437623
Email
valente.mariamaddalena@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Organizational Affiliation
IRCCS Ospedale San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Centro di Riferimento Oncologico (CRO)
City
Aviano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Buonadonna, MD
Email
abuonadonna@cro.it
Facility Name
Istituto dei tumori Giovanni Paolo II
City
Bari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Silvestris, MD
Email
silvestrisnicola@gmail.com
Facility Name
AULSS 1 di Belluno
City
Belluno
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fable Zustovich, MD
Email
fable.zustovich@aulss1.veneto.it
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Merelli, MD
Email
bmerelli@asst-pg23.it
Facility Name
Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Di Marco, MD, PhD
Email
mariacristina.dimarco@unibo.it
Facility Name
Azienda Ospedaliera AOU di Cagliari
City
Cagliari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Scartozzi, MD
Email
marioscartozzi@gmail.com
Facility Name
Ospedale di Carpi
City
Carpi
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Bernardini, MD
Email
i.bernardini@ausl.mo.it
Facility Name
USL Toscana Nord Ovest
City
Carrara
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Mambrini, MD
Email
andrea.mambrini@uslnordovest.toscana.it
Facility Name
Fondazione Istituto Giglio
City
Cefalù
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimiliano Spada, MD
Email
maxspa75@yahoo.it
Facility Name
Ospedaliera Sant' Anna di Como Asst Lariana
City
Como
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Giordano, MD
Email
monica.giordano@asst-lariana.it
Facility Name
Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia
City
Foggia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Landriscina, MD, PhD
Email
matteo.landriscina@unifg.it
Facility Name
ASST Rhodense
City
Garbagnate
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Della Torre, MD
Email
sdellatorre@asst-rhodense.it
Facility Name
Ospedale Moriggia Pelascini
City
Gravedona
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Valmadre, MD
Email
gvalmadre@gmail.com
Facility Name
Ospedale Generale Provinciale di Macerata
City
Macerata
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Faloppi, MD, PhD
Email
luca.faloppi@sanita.marche.it
Facility Name
Irccs Irst
City
Meldola
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Luca Frassineti, MD
Email
luca.frassineti@irst.emr.it
Facility Name
ASST Melegnano e Della Martesana
City
Melegnano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea De Monte, MD
Email
andrea.demonte@asst-melegnano-martesana.it
Facility Name
IRCCS San Raffaele Medical Oncology Unit
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Orsi, MD
Phone
+39 02 26437602
Email
orsi.giulia@hsr.it
First Name & Middle Initial & Last Name & Degree
Maria Maddalena Valente, PhD
Phone
+39 02 26437623
Email
valente.mariamaddalena@hsr.it
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Lonardi, MD
Email
sara.lonardi@iov.veneto.it
Facility Name
Ospedale Civico di Palermo
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Livio Blasi, MD
Email
livio.blasi61@gmail.com
Facility Name
Azienda Ospedaliera di Parma
City
Parma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Garajova, MD, PhD
Email
igarajova@ao.pr.it
Facility Name
Azienda Ospedaliera di Piacenza
City
Piacenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Cavanna, MD
Email
l.cavanna@ausl.pc.it
Facility Name
Giovanni Paolo II-Maria Paternò
City
Ragusa
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Cordio, MD
Email
stefano.cordio@asp.rg.it
Facility Name
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona
City
Salerno
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clementina Savastano, MD
Email
savastano.clementina@tiscali.it
Facility Name
AULSS 4 Veneto Orientale
City
San Donà Di Piave
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Zanon, MD
Email
silvia.zanon@aulss4.veneto.it
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evaristo Maiello, MD
Email
e.maiello@operapadrepio.it
Facility Name
Azienda Ospedaliera Ordine Mauriziano
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Di Maio, MD
Email
massimo.dimaio@unito.it
Facility Name
Presidio Ospedaliero Molinette
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Antonietta Satolli, MD, PhD
Email
mariaantonietta.satolli@unito.it
Facility Name
Azienda Sanitaria Universitaria Integrata
City
Udine
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Gerardo Cardellino, MD
Email
giovanni.cardellino@asufc.sanita.fvg.it
Facility Name
ASST Sette Laghi
City
Varese
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefania Gobba, MD
Email
stefaniamaria.gobba@asst-settelaghi.it
Facility Name
Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est
City
Vicenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Aprile, MD
Email
giuseppe.aprile@ulss8.veneto.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21626049
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.
Results Reference
background
PubMed Identifier
27404453
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.
Results Reference
background
PubMed Identifier
30220407
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.
Results Reference
background
PubMed Identifier
30149366
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.
Results Reference
background

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