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2022-07-01
2023-07-27
2023-07-27
250
NCT05587387
Yonsei University
Yonsei University
OBSERVATIONAL
Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea
Pancreatic cancer is a very aggressive disease and its prognosis is poor. Large proportion of patients diagnosed with pancreatic cancer is already in metastatic or locally advanced phases. Although there have been huge improvements in survival for many other cancers over the last few decades, the same isn't true for pancreatic cancer. Median 5-year survival rate for pancreatic cancer is around 10% and there are limited number of treatments approved for pancreatic cancer. There is no definite consensus on the best second-line chemotherapy for patients with metastatic pancreatic cancer who have progressed after first-line chemotherapy. The randomized phase III study, NAPOLI-1 trial has revealed that liposomal irinotecan (nal-IRI) plus fluorouracil/leucovorin (FL) regimen could be an acceptable treatment option in patients with metastatic pancreatic cancer who had been previously treated with gemcitabine-based chemotherapy. In this study, The investigators will evaluate how the treatment landscape has been changed since the appearance of nal-IRI in Korea. By retrospectively comparing treatment efficacy and safety outcomes before (cohort 1; without nal-IRI/FL) and after the launch of nal-IRI (cohort 2; with nal-IRI/FL), investigators will identify the degree of improvement in treatment outcome brought about by nal-IRI and will confirm whether the nal-IRI could be applied as an effective treatment option in patients with metastatic pancreatic cancer who failed first-line chemotherapy.
N/A
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 |
|---|---|---|
2022-09-26 | N/A | 2022-10-19 |
2022-10-19 | N/A | 2022-10-20 |
2022-10-20 | N/A | 2022-10 |
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 |
|---|---|
| : Cohort 1 Without Nal-IRI/FL; From Jan. 2012 to Jan. 2018 (Before launch of nal-IRI) | |
| : Cohort 2 With Nal-IRI/FL; From Jan. 2018 to Dec. 2021 (After launch of nal-IRI) |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS1) | the duration from diagnosis of pancreatic cancer to death or last follow-up - OS1 : the duration from diagnosis of pancreatic cancer to death or last follow-up | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks) |
| Overall survival (OS 2) | the duration from nal-IRI treatment initiation to death or last follow-up | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. (Up to 100 weeks) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression free survival | the duration from treatment initiation to disease progression | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse (Up to 100 weeks) |
| Objective response rate | the ratio of complete remission and partial remission | The assessment of the tumor burden after a given treatment in patients with solid tumors and has a long history(Up to 100 weeks) |
| Disease control rate | the ratio of complete remission, partial remission and stable disease | the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.(Up to 100 weeks) |
| Adverse event | adverse event during the treatment | Any undesirable experience associated with the use of a medical product in a patient.(Up to 100 weeks) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Seungmin Bang Phone Number: +82)10-6297-9209 Email: bang7028@yuhs.ac |
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.
