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2021-09-27
2022-03-01
2022-03-01
60
NCT05095064
University Hospital, Antwerp
University Hospital, Antwerp
OBSERVATIONAL
Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-09-21 | N/A | 2022-01-31 |
2021-10-13 | N/A | 2022-02-15 |
2021-10-27 | N/A | 2021-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 03/2022 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 03/2022 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
