Good Choice of pALliative Chemotherapy to Patient With Pancreatic Cancer ; GemcitAbine Therapy vs FOLFORINOX therapY

NCT ID: NCT04789980

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 799 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2025-06-24

Brief Summary

The study objectives are to find out: 1) palliative chemotherapy patterns and prognosis in patients with locally advanced or metastatic pancreatic cancer in Korea's real clinical settings, and 2) reasons adopted by clinicians in choosing therapeutic drugs.

Detailed Description

This study is a domestic, multi-center, prospective, observational study designed for locally advanced or metastatic pancreatic cancer patients who plan to receive palliative chemotherapy. When patients voluntarily express their consent to provide their information to this study by signing a written agreement, their baseline information including demographics, comorbidities, pancreatic cancer-related information, medical treatment history, etc. shall be used for screening. When patients are judged eligible for study participation, they shall receive an appropriate palliative chemotherapy. After first-line chemotherapy (baseline), information review shall be conducted at month 2, 6 and 12 for chemotherapy currently in use (whether or not chemotherapy ended/discontinued and relevant reasons; type, frequency and duration of administered drugs), RECIST, quality of life (month 2 and 6), activity performance assessment, laboratory tests, tumor marker test, adverse drug reactions, etc. However, if first-line chemotherapy moves to second-line chemotherapy due to causes such as progressive disease (PD), information review shall be restricted to the relevant drug name and survival until the end of the study (month 12).

Conditions

Locally Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer

Study Design

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

Study Groups

Patients

Patients with locally advanced or metastatic pancreatic cancer who plan to receive palliative chemotherapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients are briefed about the study objectives and methodologies, and express their consent by signing a written agreement for the use of their personal information.

2. Male and female adults who are ≥ 19 years old at the time of enrollment.

3. Locally advanced or metastatic pancreatic cancer patients whose diagnosis was confirmed histologically or cytologically.

4. Patients who plan to receive palliative chemotherapy (e.g., FOLFIRINOX, Gemcitabine-based therapy, etc.)

Exclusion Criteria

1. Patients who are diagnosed with any other primary cancer that may influence pancreatic cancer treatment or prognosis.

2. Patients who are currently or have a history of receiving palliative chemotherapy.

3. Female patients who are pregnant, have childbearing potential or are breastfeeding.

4. Patients who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the study period. However, patients participating in a non-interventional observational study or registry study can be enrolled.

5. Other patients who are judged by the investigator to be ineligible to participate in the study.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-GTB-OS-401

Identifier Type: -

Identifier Source: org_study_id