Clinical trial NCT05095064: Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan
Official title: Retrospective Study on the Efficacy and Tolerability of Liposomal irinotecanN (MM398, PEP02, Onivyde) for the Treatment of Pancreatic Adenocarcinoma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: AZ Nikolaas
name: General Hospital Groeninge
name: University Hospital St Luc, Brussels
name: ASZ Aalst
name: Erasme University Hospital
name: Centre Hospitalier Universitaire de Liege
name: OLVZ Ziekenhuis Aalst
First posted: 2021-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic pancreatic ductal adenocarcinoma

Brief summary: The aim of this retrospective study is to confirm the efficacy and safety results obtained in the NAPOLI-1-study, when Onivyde® in combination with 5-FU/LV is used in real-life practice in Belgium. The data needed to do so will be obtained using information that is routinely collected as part of patient's medical care.

Detailed description: Patients with pancreatic cancer have a poor prognosis with a 5-years survival of only 1-2%. This arises from the fact that it is typically diagnosed late, when curative resection is impossible. These patients are thus restricted to chemotherapy, with gemcitabine-based therapies being the standard of care for patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC). However, even after second or subsequent lines of therapy, disease progression is inevitable. Therefore, the need for new treatment options is high. Recently, the advantage of using nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV) over the use of 5-FU/LV alone was demonstrated in a phase-3 randomized clinical trial (NAPOLI-1 trial). As this study showed significant improvement on overall survival, progression-free survival, time to treatment failure, overall response rate and tumor marker CA19-9 response, on October 14 2016 this therapy was approved by the EMA to be used for patients with mPDAC previously treated with gemcitabine-based therapy.

While randomized clinical trials, like the NAPOLI-1 trial, are considered the reference standard for comparing the efficacy and safety of treatments, these studies do not always reflect the everyday clinical practice. Therefore, the aim of this study is to evaluate the efficacy and safety of Onivyde® in real-life practice in Belgium. This information would be very valuable to determine the value of the drug and improve the knowledge of the actual use of Onivyde® after marketing authorization.

Eligibility criteria: Inclusion Criteria:

* Patient has diagnosis of pancreatic adenocarcinoma with documented metastatic disease.
* Patient progressed after gemcitabine-based therapy.
* Patient received at least one treatment cycle with Onivyde® + 5-FU/LV 5FU in the context of post-gemcitabine based therapy of mPDAC.

Exclusion Criteria:

* Patient has not received at least one treatment cycle with Onivyde® + 5-FU/LV.
* Previous irinotecan-based therapy in metastatic setting.
* Patientstarted the treatment with Onivyde® + 5-FU/LV after 01/04/2021

Primary outcomes:
measure: The overall survival (OS) from start of treatment with Onivyde® + 5-FU/LV
timeFrame: 03/2022
Secondary outcomes:
measure: Survival rate at 2, 4, 6, 8, 10 months from the start of treatment with Onivyde® + 5-FU/LV
timeFrame: 03/2022
measure: Progression-free survival (PFS) from the start of Onivyde® + 5-FU/LV treatment
timeFrame: 03/2022
measure: Disease control rate of patients from the start of treatment with Onivyde® + 5-FU/LV
timeFrame: 03/2022
measure: Change in baseline performance status of the patient after Onivyde® + 5-FU/LV treatment
timeFrame: 03/2022
measure: The OS from the date of diagnosis of metastatic disease
timeFrame: 03/2022
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hosptital
Study officials:
affiliation: University Hospital, Antwerp
name: Marc Peeters
role: PRINCIPAL_INVESTIGATOR
References: