PAXG Out in the Country

Trial ID: NCT04480268

Interventional - Phase 4 - Unknown status

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.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

• PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy

Eligibility

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. ).

Sponsor

IRCCS San Raffaele

Source: ClinicalTrials.gov

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