PAXG Out in the Country

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    175
  • sponsor
    IRCCS San Raffaele
Updated on 19 February 2021
Investigator
Giulia Orsi, MD
Primary Contact
IRCCS Casa Sollievo della Sofferenza (0.0 mi away) Contact
+29 other location
paclitaxel
metastasis
neutrophil count
pancreatic adenocarcinoma
gemcitabine
pdac
resectable pancreatic ductal adenocarcinoma

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.

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.

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
Clinical Study IdentifierNCT04480268
SponsorIRCCS San Raffaele
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

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. )
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