PAXG Out in the Country (OINC)

February 8, 2021 updated by: Michele Reni, IRCCS San Raffaele
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

175

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Aviano, Italy
        • Not yet recruiting
        • Irccs Centro Di Riferimento Oncologico (CRO)
      • Bari, Italy
      • Belluno, Italy
      • Bergamo, Italy
      • Bologna, Italy
        • Not yet recruiting
        • Azienda ospedaliera policlinico Sant'Orsola-Malpighi
        • Contact:
      • Cagliari, Italy
      • Carpi, Italy
      • Carrara, Italy
      • Cefalù, Italy
        • Not yet recruiting
        • Fondazione Istituto Giglio
        • Contact:
      • Como, Italy
      • Foggia, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia
        • Contact:
      • Garbagnate, Italy
      • Gravedona, Italy
        • Not yet recruiting
        • Ospedale Moriggia Pelascini
        • Contact:
      • Macerata, Italy
      • Meldola, Italy
      • Melegnano, Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Medical Oncology Unit
      • Padova, Italy
      • Palermo, Italy
      • Parma, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Di Parma
        • Contact:
      • Piacenza, Italy
        • Not yet recruiting
        • Azienda Ospedaliera di Piacenza
        • Contact:
      • Ragusa, Italy
      • Salerno, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
        • Contact:
      • San Donà Di Piave, Italy
      • San Giovanni Rotondo, Italy
      • Torino, Italy
      • Torino, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Ordine Mauriziano
        • Contact:
      • Udine, Italy
      • Varese, Italy
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. ).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival at 1 year (PFS-1yr)
Time Frame: 12 months after the diagnosis
Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
12 months after the diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Response
Time Frame: 12 months after the diagnosis
To evaluate the CA19-9 response rate
12 months after the diagnosis
Radiological Response
Time Frame: 12 months after the diagnosis
To evaluate the RECIST radiological response
12 months after the diagnosis
Toxicity profile
Time Frame: 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
12 months after the diagnosis
Progression-free survival (PFS)
Time Frame: 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.
5 year after the diagnosis
Overall Survival (OS)
Time Frame: 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.
5 year after the diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Michele Reni, MD, IRCCS Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACT31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Ductal Adenocarcinoma

Clinical Trials on PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe