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

NCT ID: NCT05587387

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-07-27

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.

Conditions

Pancreatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1

Without Nal-IRI/FL; From Jan. 2012 to Jan. 2018 (Before launch of nal-IRI)

No interventions assigned to this group

Cohort 2

With Nal-IRI/FL; From Jan. 2018 to Dec. 2021 (After launch of nal-IRI)

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seungmin Bang

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seungmin Bang

Role: CONTACT

bang7028@yuhs.ac

+82)10-6297-9209

Facility Contacts

Seungmin Bang

Role: primary

bang7028@yuhs.ac

+82)10-6297-9209

Other Identifiers

4-2022-0776

Identifier Type: -

Identifier Source: org_study_id