Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05587387

Collaborator

(none)

250

Enrollment

Location

12.8

Anticipated Duration (Months)

19.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Change of Treatment Landscape and Survival in Metastatic Pancreatic Cancer After Nal-IRI in Republic of Korea

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 27, 2023

Anticipated Study Completion Date :

Jul 27, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Overall survival (OS1) [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)]
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
Overall survival (OS 2) [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)]
the duration from nal-IRI treatment initiation to death or last follow-up

Secondary Outcome Measures

Progression free survival [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)]
the duration from treatment initiation to disease progression
Objective response rate [The assessment of the tumor burden after a given treatment in patients with solid tumors and has a long history(Up to 100 weeks)]
the ratio of complete remission and partial remission
Disease control rate [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)]
the ratio of complete remission, partial remission and stable disease
Adverse event [Any undesirable experience associated with the use of a medical product in a patient.(Up to 100 weeks)]
adverse event during the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients initially diagnosed as locally advanced pancreatic cancer or metastatic pancreatic cancer and received chemotherapy between 2012 and 2021
Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines
Locally advanced pancreatic cancer; disease status was defined by NCCN guidelines.
Recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
At least 18 years of age

Exclusion Criteria:

Other histology (ex. Neuroendocrine tumor, etc.)
Cohort 2 (other regimens); Patients who received nal-IRI at least once after diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Seungmin Bang, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05587387

Other Study ID Numbers:

4-2022-0776

First Posted:

Oct 20, 2022

Last Update Posted:

Oct 20, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Oct 20, 2022