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

Recruiting

• Conditions: Metastatic Pancreatic Cancer; Locally Advanced Pancreatic Cancer

• Registration Number: NCT04789980
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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).

Study Timeline

• Study Start: 2021-01-29
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-07
• Study First Posted: 2021-03-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemotherapy patterns(Type of the second-line palliative chemotherapy)	up to 12 months	Type of the second-line palliative chemotherapy for each first-line palliative chemotherapy
Progression-free survival (PFS)	From date of the first tumor response until the date of first documented progression, assessed up to 12 months	Progression-free survival (PFS) by first-line palliative chemotherapy
Overall Survival (OS)	From date of enrollment until the date of death, assessed up to 12 months	Overall Survival (OS) by first-line palliative chemotherapy
Chemotherapy patterns(Type of the first-line palliative chemotherapy)	Baseline	Type of the first-line palliative chemotherapy and reasons for therapy selection/discontinuation

Secondary Outcome Measures

Name	Time	Method
Total administration period	through the first-line chemotheraphy completion, assessed up to 12 months	Total administration period of the first palliative chemotherapy.
The best response	through the first-line chemotheraphy completion, assessed up to 12 months	The best response according to RECIST 1.1 criteria, objective response rate (ORR) and disease control rate (DCR)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) scores	Baseline, Month 2, Month 6, Month 12	Changes in ECOG PS scores at month 2, 6 and 12 after palliative chemotherapy compared to previous therapy. The minimum value is 0 and the maximum value is 5, and higher scores mean a worse outcome.
Quality of Life Assessment	Baseline, Month 2, Month 6	Quality of life (FACT-Hep) changes in month 2 and 6 after palliative chemotherapy compared to previous therapy

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of