Status:
ACTIVE_NOT_RECRUITING
RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan
Lead Sponsor:
Servier Affaires Médicales
Conditions:
Pancreatic Cancer Metastatic
Eligibility:
All Genders
18+ years
Brief Summary
The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI
Detailed Description
The objectives on patients still alive one year after the first cycle of nal-IRI : * Characterize mPDAC patient population according to their demographics * Identify PDAC treatment by line of treatme...
Eligibility Criteria
Inclusion
- Age ≥ 18 years (≥ 19 years in South Korea)
- Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
- All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
- Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
- At least one cycle of nal-IRI-containing regimen should have been administered
- A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
- Availability of data related to survival outcomes in the patient medical record
- Patients deceased or not at the time of enrollment will be eligible for inclusion in the study
Exclusion
- No documentation of systemic therapy outcomes or prior treatments in patient medical records
- Patients with second concomitant metastatic malignancy
Key Trial Info
Start Date :
October 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT06155136
Start Date
October 6 2023
End Date
September 30 2024
Last Update
April 22 2024
Active Locations (1)
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1
Klinikum der Universität München, - Anstalt des öffentlichen Rechts -
Munich, Germany, 81377