RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan

Pancreatic Cancer Metastatic Clinical Trial

— NALLONG  

Official title:

Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06155136
• Other study ID #: DIM-95013-001-INT
• Status: Active, not recruiting
• Start date: October 6, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

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 treatment from diagnosis to last treatment - Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: September 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• No documentation of systemic therapy outcomes or prior treatments in patient medical records
• Patients with second concomitant metastatic malignancy

Related Conditions & MeSH terms

• Pancreatic Cancer Metastatic

Locations

Country	Name	City	State
Germany	Klinikum der Universität München, - Anstalt des öffentlichen Rechts -	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease characteristic according to age	Tumor stage (localized/locally advanced/metastatic)	Through study completion (approximatively 5 months)