Pancreatic Adenocarcinoma Metastatic
Conditions
Keywords
pancreatic adenocarcinoma
Brief summary
The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice
Detailed description
Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial. Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales. However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount
Interventions
None listed
Sponsors
Servier
University Hospital, Bordeaux
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * histological or cytological confirmation of pancreatic ductal adenocarcinoma * measurable lesion(s) * progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil. * Performance Status (PS) 0 or 1 * Oral consent * Health insurance
Exclusion criteria
* symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease) * thromboembolic events within six months of inclusion; * Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension. * Patient under legal protection * Hypersensitivity to irinotecan * Breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | Up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate to treatment | Every 3 months up to 3 years | Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI). Duration of treatment is calculated from the day of nal-IRI initiation to the day of disease progression, switch to other treatment regimens or when the patient is lost to follow-up. Tumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9. |
| Progression-free survival | Every 3 months up to 3 years | — |
| Cost evaluation | Every 3 months up to 3 years | number of vials per patient |
Countries
France
Outcome results
None listed