Status:
COMPLETED
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Servier
Conditions:
Pancreatic Adenocarcinoma Metastatic
Eligibility:
All Genders
18+ years
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 irinotec...
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 II...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06006728
Start Date
October 6 2023
End Date
October 31 2023
Last Update
January 12 2024
Active Locations (1)
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1
CHU Bordeaux
Pessac, France