An observational study in Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by University Hospital, Antwerp. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by University Hospital, Antwerp · Observational
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.
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 60 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.
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Metastatic pancreatic ductal adenocarcinoma
Exclusion Criteria:
Nanoliposomal irinotecan (Onivyde®) in combination with 5-fluorouracil and leucovorin (5-FU/LV)
Also known as: Nanoliposomal irinotecan
The overall survival (OS) from start of treatment with Onivyde® + 5-FU/LV
All this info is retrospectively obtained from the patients medical fistory. Data analysis is forseen to be finished 03/2022.
Time frame: 03/2022
Survival rate at 2, 4, 6, 8, 10 months from the start of treatment with Onivyde® + 5-FU/LV
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Time frame: 03/2022
Progression-free survival (PFS) from the start of Onivyde® + 5-FU/LV treatment
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Time frame: 03/2022
Disease control rate of patients from the start of treatment with Onivyde® + 5-FU/LV
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Time frame: 03/2022
Change in baseline performance status of the patient after Onivyde® + 5-FU/LV treatment
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Time frame: 03/2022
The OS from the date of diagnosis of metastatic disease
All this info is retrospectively obtained from the patients medical history. Data analysis is forseen to be finished 03/2022.
Time frame: 03/2022
Plan to share: No
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp