Clinical trial NCT06006728: Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Official title: Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Adenocarcinoma Metastatic
Keywords: pancreatic adenocarcinoma
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Servier
First posted: 2023-08-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Response rate to treatment
timeFrame: Every 3 months up to 3 years
measure: Progression-free survival
timeFrame: Every 3 months up to 3 years
measure: Cost evaluation
timeFrame: Every 3 months up to 3 years
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux
Study officials:
References: