Advanced pancreatic adenocarcinoma
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs) and related TEAEs (TRAEs) according to CTCAE V5.0 and of clinically relevant changes in laboratory data, vital signs, and physical examination
Detailed description
Overall response (OR), disease control (DC), duration of response (DOR), and duration of stable disease, measured by CT or MRI and assessed per RECIST 1.1 criteria, Progression-free survival (PFS), measured by CT or MRI and assessed per RECIST 1.1 criteria, Overall survival (OS), Pharmacokinetic parameters of products including, but not limited to, maximum plasma concentration (Cmax) and trough concentrations (Ctrough).
Interventions
DRUGPACLITAXEL
DRUGOXALIPLATIN
DRUGIRINOTECAN
DRUGFLUOROURACIL
DRUGGEMCITABINE
DRUGCALCIUM FOLINATE
Sponsors
Asociacion Grupo Tratamiento De Tumores Digestivos
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and related TEAEs (TRAEs) according to CTCAE V5.0 and of clinically relevant changes in laboratory data, vital signs, and physical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response (OR), disease control (DC), duration of response (DOR), and duration of stable disease, measured by CT or MRI and assessed per RECIST 1.1 criteria, Progression-free survival (PFS), measured by CT or MRI and assessed per RECIST 1.1 criteria, Overall survival (OS), Pharmacokinetic parameters of products including, but not limited to, maximum plasma concentration (Cmax) and trough concentrations (Ctrough). | — |
Countries
France, Spain
Outcome results
None listed