Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy

Completed

• Conditions: Pancreatic Adenocarcinoma Metastatic

• Registration Number: NCT06006728
• Lead Sponsor: University Hospital, Bordeaux

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

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-10-06
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Every 3 months up to 3 years
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.
Cost evaluation	Every 3 months up to 3 years	number of vials per patient

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Pessac, France