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Trial Title:
Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea
NCT ID:
NCT05587387
Condition:
Pancreatic Neoplasms
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Summary:
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.
Criteria for eligibility:
Study pop:
In multiple medicatl center, such as Sinchon Severance hospital, Gangnam Severance
hospital, Gachon University Gil hospital and Konkuk University hospital, investigators
will collect the medical information according to inclusion criteria and exclusion
criteria from 2012 to 2021.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Patients initially diagnosed as locally advanced pancreatic cancer or metastatic
pancreatic cancer and received chemotherapy between 2012 and 2021
2. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
3. Documented metastatic disease; disease status may be measurable or non-measurable as
defined by RECIST v1.1 guidelines
4. Locally advanced pancreatic cancer; disease status was defined by NCCN guidelines.
5. Recovered from the effects of any prior surgery, radiotherapy, or other
antineoplastic therapy
6. At least 18 years of age
Exclusion Criteria:
1. Other histology (ex. Neuroendocrine tumor, etc.)
2. Cohort 2 (other regimens); Patients who received nal-IRI at least once after
diagnosis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seungmin Bang
Phone:
+82)10-6297-9209
Email:
bang7028@yuhs.ac
Start date:
July 1, 2022
Completion date:
July 27, 2023
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05587387
