PAXG Out in the Country

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Treatments: Capecitabine; Gemcitabine; Paclitaxel

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. ).