Status:
UNKNOWN
PAXG Out in the Country
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 resecta...
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. A...
Eligibility Criteria
Inclusion
- 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
- 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. ).
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT04480268
Start Date
July 8 2020
End Date
January 1 2026
Last Update
February 10 2021
Active Locations (30)
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1
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, Italy
2
Istituto dei tumori Giovanni Paolo II
Bari, Italy
3
AULSS 1 di Belluno
Belluno, Italy
4
ASST Papa Giovanni XXIII
Bergamo, Italy