Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
NCT ID: NCT06006728
Last Updated: 2024-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
58 participants
OBSERVATIONAL
2023-10-06
2023-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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naliri
Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Servier
INDUSTRY
University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU Bordeaux
Pessac, , France
Countries
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Other Identifiers
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CHUBX 2023/14
Identifier Type: -
Identifier Source: org_study_id
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